Repeated Endoscopic Dilation and Needle Knife Stricturotomy for Crohn's Disease Strictures.

BACKGROUND AND AIMS: Crohn's disease strictures are usually treated by a single endoscopic balloon dilation (EBD). We postulated repeat EBD and needle-knife stricturotomy (NKSt), together with inflammation controlled by intense drug therapy, may be more effective. METHODS: 21 patients with symptomatic strictures were randomised to single EBD or intensive treatment with 3 balloon dilations 3 weeks apart and/or NKSt RESULTS: Of 21 patients 2 of 5 (40%) five with a single EBD and 12/16 [72%] with intensive treatment had symptom improvement (OR 4.49 [95% CI 0.54 - 37.4]; P = 0.164). Eleven patients received >1 EBD without NKSt, 5 had ≥1 NKSt. NKSt treated patients and those with concurrent intensified drug treatment had the best outcomes. CONCLUSIONS: Crohn's disease stricture treatment with repeat dilations or stricturotomy is feasible, safe and may improve stricture outcomes. Concurrent intensified drug treatment to eliminate inflammation is also associated with improved outcome.

Investigating PSMA-PET/CT to resolve prostate MRI PIRADS4-5 and negative biopsy discordance.

BACKGROUND: To determine the utility of diagnostic 18F-DCPyL PSMA-PET/CT to aid management of men with highly suspicious multiparametric MRI prostate (PIRAD 4-5 lesions) and discrepant negative prostate biopsy. METHODS: A multicentre prospective consecutive case series was conducted (2018-2021), recruiting men with prior mpMRI prostate PIRADS 4-5 lesions and negative prostate biopsy. All men had 18F-DCPyL PSMA-PET/CT with subsequent management based on the concordance between MRI and PET: (1) Concordant lesions were biopsied using in-bore MRI targeting; (2) PSMA-PET/CT avidity without MRI correlate were biopsied using cognitive/software targeting with ultrasound guidance and (3) Patients with negative PET/CT were returned to standard of care follow-up. RESULTS: 29 patients were recruited with 48% (n = 14) having concordant MRI/PET abnormalities. MRI targeted biopsy found prostate cancer in six patients, with grade groups GG3 (n = 1), GG2 (n = 1), GG1 (n = 4) found. Of the 20 men who PSMA-PET/CT avidity and biopsy, analysis showed higher SUVmax (20.1 vs 6.8, p = 0.036) predicted prostate cancer. Of patients who had PSMA-PET avidity without MRI correlate, and those with no PSMA-PET avidity, only one patient was subsequently found to have prostate cancer (GG1). The study is limited by small size and short follow-up of 17 months (IQR 12.5-29.9). CONCLUSIONS: PSMA-PET/CT is useful in this group of men but requires further investigation. Avidity (higher SUVmax) that correlates to the mpMRI prostate lesion should be considered for targeted biopsy.

Non-prostate cancer tumours: incidence on 18F-DCFPyL PSMA PET/CT and uptake characteristics in 1445 patients.

PURPOSE: With increasing use of PSMA PET/CT in the staging and restaging of prostate cancer (PCa), the identification of non-prostate cancer tumours (NPCaT) has become an increasing clinical dilemma. Atypical presentations of PSMA expression in prostate cancer and expression in NPCaT are not well established. Understanding the normal and abnormal distribution of PSMA expression is essential in preparing clinically relevant reports and in guiding multidisciplinary discussion and decisions. METHODS: Retrospective review of 1445 consecutive 18F-DCFPyL PSMA PET/CT studies by experienced radiologists and nuclear medicine physicians. Lesions indeterminate for PCa were identified. Correlation was made with patient records, biopsy results, and dedicated imaging. Lesions were then categorized into four groups: 1. Confirmed prostate cancer, metastases, 2. NPCaT 3. Benign, and 4. Indeterminate lesions. RESULTS: 68/1445 patients had lesions atypical for prostate cancer metastases. These comprised 8/68 (11.8%) atypical prostate cancer metastases, 17/68 (25.0%) NPCaT, 29/68 (42.6%) indeterminate, and 14/68 (20.6%) benign. In the context of the entire cohort, these are adjusted to 8/1445 (0.6%), 17/1445 (1.2%), 29/1445 (2.0%), and 14/1445 (1.0%) respectively. With the exception of Renal Cell Carcinoma (RCC), NPCaT demonstrated no or low PSMA expression. A similar trend was also observed for indeterminate and benign lesions. Conversely, most atypical PCa metastases demonstrated intermediate or high PSMA expression. CONCLUSION: 18F-DCFPyL PSMA PET/CT detection of NPCaT is low. Lesions demonstrating intermediate to high PSMA expression were exclusively prostate cancer metastases, aside from RCC, and lesions detected in organs with high background expression.

Pathological predictors of 18 F-DCFPyL prostate-specific membrane antigen-positive recurrence after radical prostatectomy.

OBJECTIVES: To assess the correlation of pathological radical prostatectomy (RP) specimen features and prostate-specific antigen (PSA) characteristics to imaging findings on subsequent 18 F-DCFPyL positron emission tomography/computed tomography (PET/CT) in patients with biochemical failure (BF). PATIENTS AND METHODS: Retrospective analysis of combined 18 F-DCFPyL PET/CT database of patients from centres in Australia and New Zealand was performed. A total of 205 patients presenting with BF after RP were included in this study. Imaging findings on 18 F-DCFPyL PET/CT were recorded and correlated with the PSA characteristics at BF and pathological features of the original tumour. RESULTS: Of the 205 patients, 120 (58.5%) had evidence of abnormal prostate-specific membrane antigen (PSMA) expression compatible with recurrent prostate cancer. Increasing PSA velocity (P = 0.01), International Society of Urological Pathology (ISUP) Grade Group (P = 0.02), lymphovascular invasion (P = 0.05) and nodal positivity (P = 0.02) at the time of RP were more likely to demonstrate PSMA positivity. Multivariable logistic regression revealed a higher PSA level prior to PSMA PET/CT (P < 0.01), adjuvant radiotherapy (P = 0.09), Gleason score ≥8 (P < 0.01) and nodal positivity (P = 0.05) were all predictive of PSMA positivity. CONCLUSION: 18 F-DCFPyL PET/CT positivity, both generally and site specific, correlates with PSA and RP pathological factors. Our results echo cohorts focussing on post-RP patients, those imaged with 68 Ga-PSMA and those concerning biochemical persistence. Nomograms that include risk factors for 'PSMA-positive recurrence' in the BF population may increase the catchment of patients with disease confined to the prostate bed or pelvis who have a greater probability of prolonged disease-free survival.

Verbal notification of radiology results: are radiologists meeting expectations?

BACKGROUND: Delayed communication of radiographic findings is associated with poor patient outcomes and significant medicolegal risk. Radiologists verbally contact referring practitioners with urgent findings, although practitioner's expectations regarding notification have rarely been examined. AIM: To assess differences in preferred practice between radiologists and referring practitioners in the verbal communication of urgent radiology findings. METHODS: For 33 clinical stems, respondents were asked if they would issue (radiologists) or expect to receive (referring practitioners) verbal notification of results or routine written communication only. Surveys were emailed to radiologists and referring practitioners of varying experience at a tertiary referral hospital in Melbourne, Victoria. RESULTS: A total of 97 survey responses was received. Eighty responses were from referring practitioners and 17 from radiologists. Referring practitioners were seen to slightly prefer verbal notification more often than issued by radiologists overall (61%; 95% confidence interval (CI) 57-66% verbal notification expected vs 58%; 95% CI 52-64% issued). More senior referring practitioners with greater than 10 years' experience expected verbal notification more often (67%; 95% CI 59-75%), and more senior radiologists issued verbal reports less often (54%; 95% CI 39-69%). More junior referring practitioners, for example, registrars or fellows, expected notification less often overall (59%; 95% CI 43-76%). Subgroup analysis demonstrated statistically significant differences in notification preferences for certain clinical scenarios. CONCLUSIONS: Overall results show fair correlation between referrer's expectations of verbal notification and the provision of verbal notification by radiologists. However, there were discrepancies in the practice and preferences of more junior and senior practitioners in certain clinical scenarios.

[18F]DCFPyL PET/CT in detection and localization of recurrent prostate cancer following prostatectomy including low PSA < 0.5 ng/mL.

PURPOSE: The primary aim of this retrospective multicenter analysis was to assess the performance of PSMA PET/CT using [18F]DCFPyL in the detection and localization of recurrent prostate cancer post radical prostatectomy (RP). Particular reference is given to low PSA groups < 0.5 ng/mL to aid discussion around the inclusion of this group in PSMA guidelines and funding pathways. METHODS: Retrospective analysis of combined PSMA database patients from centers in Australia and New Zealand. Two hundred twenty-two patients presenting with recurrence post RP were stratified into five PSA groups (ng/mL): 0-0.19, 0.2-0.49, 0.5-0.99, 1-1.99, and ≥ 2. Lesions detected by [18F]DCFPyL PET/CT were recorded as local recurrence, locoregional nodes, and metastases. RESULTS: Of 222 patients, 155 (69.8%) had evidence of abnormal uptake suggestive of recurrent prostate cancer. The detection efficacies for [18F]DCFPyL PET/CT were 91.7% (44/48) for PSA levels ≥ 2 ng/mL, 82.1% (23/28) for PSA levels 1-1.99 ng/mL, 62.8% (27/43) for PSA levels 0.5-0.99 ng/mL, 58.7% (54/92) for PSA levels 0.2-0.49 ng/mL, and 63.6% (7/11) for PSA levels ≤ 0.2 ng/mL. In those with PSA < 0.5 ng/mL, 47.6% (49/103) had detectable lesions, 71.4% (35/49) had disease confined to the pelvis, 22.4% (11/49) had prostate bed recurrence, 49.0% (24/49) had pelvic lymph nodes, and 28.6% (14/49) had extra pelvic disease. CONCLUSION: [18F]DCFPyL PET/CT has a high detection rate in recurrence following RP even at low PSA levels with similar detection levels in the PSA subgroups < 0.5 ng/mL. Employing rigid PSA thresholds when constructing guidelines for PSMA PET/CT funding eligibility may result in a significant number of patients below such thresholds having delayed or inappropriate treatment.

Funding of prostate magnetic resonance imaging leads to fewer biopsies and potential savings to health systems in the management of prostate cancer.

OBJECTIVES: To assess the impact of the introduction of multiparametric magnetic resonance imaging of the prostate (mpMRIp) on the number of prostate biopsies performed in Australia. METHODS: Australian Medicare published statistics from 1 July 2007 to 30 June 2019 were obtained from publically available databases for prostate-specific antigen (PSA) testing, prostate biopsy, and mpMRIp. Analysis was divided into three time periods broadly based on availability of mpMRI to the Australian public: 2007-2012 (no mpMRIp), 2012-2018 (mpMRIp available, privately funded), and 2018-2019 (mpMRIp available with Medicare funding). Introduction of mpMRIp was hypothesised to reduce the number of prostate biopsies performed. PSA testing numbers were used as a control. The economics model, proposed by the Medical Services Advisory Committee (MSAC), was analysed for cost savings. RESULTS: Accounting for variations in PSA testing, the introduction of mpMRIp from 2012 coincided with a reduction in the number of prostate biopsies by an average of 354.7/month (95% CI 175, 534.4; P < 0.001). Whilst the number of mpMRIp performed for the initial 12 months was underestimated by the MSAC at 38 470 vs 20 149 (+$8.3 million Australian dollars), we estimate the annual savings from reduced number biopsies and biopsy-associated complications to be $13.2 ± 9.6 million. CONCLUSION: Availability of mpMRIp in Australia has correlated with a significant reduction in prostate biopsy rates, with an estimated annual saving of $13.2 ± 9.6 million. Government funding of this diagnostic service has the potential to improve health equity and save on health expenditure.

Magnetic resonance enterography for predicting the clinical course of Crohn's disease strictures.

BACKGROUND AND AIMS: Strictures are the most common Crohn's disease complication, but their natural history is unknown. This study aimed to characterize inflammation, predict prognosis, and understand the impact of drug therapy using magnetic resonance enterography (MRE). METHODS: Patients with a stricture diagnosed on MRE over a 5-year period were reviewed for MRE disease extent and inflammation, clinical course, C-reactive protein, response to anti-TNF therapy, endoscopic dilatation, hospitalization, and surgery. RESULTS: 136 patients had 235 strictures (77, one and 59, ≥ 2 strictures). TREATMENT: 46% of patients underwent surgery after a median 6 months; median follow-up for those not requiring surgery was 41 months. Predictors of surgery: Hospitalization because of obstruction predicted subsequent surgery (OR 2.50; 95% CI 1.06-5.90) while anti-TNF therapy commenced at stricture diagnosis was associated with a reduced risk (OR 0.23; 95% CI 0.05-0.99). MRE characteristics associated with surgery were proximal bowel dilatation ≥ 30-mm diameter (OR 2.98; 95% CI 1.36-6.55), stricture bowel wall thickness ≥ 10-mm (OR 2.42; 95% CI 1.11-5.27), and stricture length > 5-cm (OR 2.56; 95% CI 1.21-5.43). 81% of patients with these three adverse MRE features required surgery versus 17% if none were present (P < 0.001). Accuracy for these three MRE variables predicting surgery was high (AUC 0.76). CONCLUSION: Magnetic resonance enterography findings in Crohn's disease strictures are highly predictive of the disease course and the need for future surgery. MRE may also identify who would benefit from treatment intensification. Anti-TNF therapy is associated with reduced risk of surgery and appears to alter the natural history of this complication.

Contrast-enhanced sonographic appearances of two primary hepatic epithelioid angiomyolipomas.

Epithelioid hepatic angiomyolipoma (Epi-HAML) is a rare hepatic tumor frequently misdiagnosed as hepatocellular carcinoma (HCC). Unlike conventional angiomyolipoma (AML), Epi-HAML contains minimal amount of adipose tissue, which is a radiological distinguishing feature between AML and HCC. Two patients were referred for management of incidentally found hepatic lesions confirmed to be Epi-HAML on post-resection tissue analysis. CT and MRI findings were suggestive of HCC. Contrast-enhanced ultrasound demonstrated intratumoral shunting, a feeding artery, and early draining hepatic vein. These findings should alert radiologists to the possibility of Epi-HAML. Furthermore, these features may be better assessed by contrast-enhanced ultrasound due to its superior dynamic temporal resolution.

Evaluation of the accuracy of multiparametric MRI for predicting prostate cancer pathology and tumour staging in the real world: an multicentre study.

OBJECTIVES: To assess the accuracy of multiparametric magnetic resonance imaging (mpMRI) for the detection of significant prostate cancer in men undergoing radical prostatectomy (RP) in an Australian multicentre setting, and to assess concordance between mpMRI and RP for local tumour staging and index lesion locations. PATIENTS AND METHODS: Men who underwent mpMRI within 12 months of RP between January 2013 and August 2016 at three Australian sites were included (Central Coast, NSW, St Vincents Hospital, Melbourne, Vic., and Bendigo Hospital, Vic.). The results of mpMRI were compared with the final RP specimen to analyse the performance of mpMRI for significant prostate cancer detection, index lesion localization, prediction of T3 disease and lymph node metastasis. A comparison between mpMRI cases performed using the technical and reporting specifications of Prostate Imaging Reporting and Data System (PI-RADS) version 1 and version 2 was also performed. Data analysis was performed using spss 24.0. RESULTS: A total of 235 cases were included for analysis. mpMRI PI-RADS score ≥3 had a 91% sensitivity and 95% positive predictive value (PPV) for significant prostate cancer at RP. The overall concordance between index lesion location on mpMRI and RP specimen was 75%. The sensitivity for predication of significant prostate cancer was higher in the PI-RADS version 2 cases compared with PI-RADS version 1 (87-99%; P = 0.005). Index lesion concordance was higher in the PI-RADS version 2 group (68% vs 91%; P = 0.002). mpMRI had a 38% sensitivity, 95% specificity, 90% PPV and 57% negative predictive value for extraprostatic disease. Sensitivity for prediction of T3 disease improved from 30% to 62% (P = 0.008) with PI-RADS version 2. CONCLUSIONS: In patients undergoing RP, an abnormal mpMRI is highly predictive (95% PPV) of significant prostate cancer, with an index lesion concordance of 75%. There has been a significant improvement in accuracy after the adoption of PI-RADS version 2 technical specifications and reporting criteria; however; further study is required to determine if this is attributable to improved experience with mpMRI or changes in the PI-RADS system.

Hypophysitis due to IgG4-related disease responding to treatment with azathioprine: an alternative to corticosteroid therapy.

PURPOSE: Fifteen cases of lymphocytic hypophysitis due to IgG4-related disease have been reported demonstrating marked improvement with corticosteroid therapy. This is the first case of IgG4-related hypophysitis demonstrating improvement with azathioprine, where corticosteroids were initially tried but ceased due to concern regarding enlargement of the pituitary infiltrate. METHODS: Case description and review of 15 cases reported in the literature. A 40 year old male was diagnosed with IgG-4 related disease based on pituitary and lacrimal gland biopsies associated with raised serum concentration of IgG4. The patient was commenced on prednisolone 30 mg/day, as rapid response to prednisolone treatment has been described in the literature for other cases of IgG4-related hypophysitis. Over the next 3 months, prednisolone treatment resulted in a reduction of serum IgG4 levels, but repeat MRI scan showed an enlarging pituitary mass with new optic nerve compression. Azathioprine 75 mg twice daily was commenced and in the subsequent 3 months, IgG4 levels normalised (0.58 g/L) and MRI scan showed 50% shrinkage of the pituitary mass. After 10 months of azathioprine treatment the MRI showed a normal sized pituitary but persistence of the infraorbital nerve thickening. CONCLUSIONS: Hypophysitis due to IgG4-related disease usually demonstrates prompt response to corticosteroids. This case highlights the need to image promptly after starting treatment to exclude an enlarging pituitary mass despite corticosteroid treatment. Alternative therapy with azathioprine can result in marked improvement. It should be remembered that IgG-4 related hypophysitis is part of a multi-organ disease.

Contrast enhanced ultrasound (CEUS) in the diagnosis of post-partum bilateral renal cortical necrosis: a case report and review of the literature.

Renal cortical necrosis is a rare condition with complex pathogenesis. There is no consensus over the best investigative modality for an initial diagnosis that is often in the context of acute renal failure. The applications of ultrasound contrast are ever growing, particularly with regard to the assessment of abdominal organs. Here, we present a case of post-partum bilateral renal cortical necrosis affecting bilateral native kidneys and the subsequent use of contrast enhanced ultrasound in confirming this diagnosis. The sonographic appearance was found to correlate with the patients' clinical presentation and other imaging findings. Secondarily, this allowed for appropriate and timely medical management and establishes the utility of ultrasound contrast in this clinical scenario. Contrast enhanced sonographic assessment should be considered early in patients with suspected renal vascular compromise. It is a safe, easy and efficacious investigative modality to stratify those patients with renal cortical necrosis from those with potentially reversible medical causes.

Micro-enema immediately prior to prostate MRI: effects on rectal gas, image quality and PI-QUAL score.

PURPOSE: Our aim was to determine whether the administration of a micro-enema immediately prior to prostate MRI is associated with a reduction in rectal gas, gas related artifacts and an improvement in image quality and PI-QUAL score. METHOD: This retrospective analysis enrolled 171 patients who underwent multiparametric 3T prostate MRI at our institution between January 2021 and September 2022. 86 patients received a micro-enema, and a further 85 patients did not. Two fellowship trained abdominal radiologists were blinded and independently reviewed each prostate MRI, recording scores on a dedicated scoring sheet. The quality of T2 weighted (T2W), diffusion weighted (DWI), and dynamic contrast enhancement (DCE) images were assessed according to standardised scales supported in the literature. In addition, gas related artifacts and rectal gas level were examined. An independent-samples Mann-Whitney U and t-test were performed, comparing both the median and mean score between micro-enema and no micro-enema groups for each reader. Spearman's correlation was used to determine the strength of relationship between variables. A quadratic weighted Cohen's Kappa and percent agreement were used to assess inter-observer agreement. RESULTS: Image quality was improved in those who received the micro-enema compared to those who did not according to the visual grading scale on the DWI sequence for both readers (reader 1: median 4 vs. 4, p < 0.001, mean 4.27 vs. 3.92, p < 0.001; reader 2: median 5 vs. 4, p < 0.001, mean 4.74 vs. 4.14, p < 0.001). PI-QUAL score was significantly improved in the micro-enema group for reader 2 only (reader 1: median 4 vs. 4, p = 0.25, mean 3.99 vs. 4.08, p = 0.21; reader 2: median 5 vs. 5, p = 0.01, mean 4.95 vs. 4.78, p = 0.01). Visual grading score for both the T2W and DCE images was not significantly different. Rectal gas level was lower in patients who received the micro-enema for both readers (reader 1: median 2 vs. 4, p < 0.001, mean 2.12 vs. 3.60, p < 0.001; reader 2: median 1 vs. 2, p < 0.001, mean 1.37 vs. 2.48, p < 0.001), correlating with a lower score for gas-related artifacts (reader 1: median 1 vs. 2, p < 0.001, mean 1.50 vs. 1.92, p < 0.001; reader 2: median 1 vs. 1, p < 0.001, mean 1.16 vs. 1.71, p < 0.001) in this group. Correlation between rectal gas level and gas-related artifacts on DWI regardless of whether a micro-enema was given was strong (rs = 0.71, p < 0.001). Correlation was moderate to strong between rectal gas level and image quality on DWI (rs = -0.63, p < 0.001). There was only 1 (1.2%) borderline diagnostic or non-diagnostic DWI sequence in those who received the micro-enema, compared to 9 (10.6%) in those who did not (p = 0.009). Interobserver agreement was moderate for image quality on DWI, gas related artifacts and rectal gas level (weighted kappa values of 0.52, 0.49 and 0.53 respectively). CONCLUSIONS: The administration of a micro-enema immediately prior to prostate MRI is associated with a significant improvement in image quality on the DWI sequence compared to no bowel preparation. This is mediated through a reduction in rectal gas and gas related artifacts. Improvements in PI-QUAL score was mixed between readers.

Effect of laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass on body composition.

BACKGROUND: There is limited data with respect to body composition changes for laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB). The objective of this study was to analyse changes in body composition between these two procedures during the first year after bariatric surgery. METHODS: A prospective study was performed in patients undergoing bariatric surgery at two tertiary hospitals between 2017 and 2023. Body composition was assessed with dual-energy x-ray absorptiometry immediately before surgery, and at 1-, 6-, 12-, 18- and 24-months post-operatively, with a subgroup analysis performed for patients who undertook a scan at 18- and 24-months. Total weight loss (TWL), body mass index (BMI), fat mass (FM), lean body mass (LBM) and bone mineral content (BMC) parameters were compared between SG and RYGB. RESULTS: Forty-five patients were included in this series (SG n = 30, RYGB n = 15). There was a significant reduction in mean %TWL of 26.94 ± 8.86% and mean BMI of 11.12 ± 3.70 kg/m2 over 12-months. LBM accounted for 17.8% of TWL over 12-months, SG and RYGB did not differ in terms of loss of FM or LBM. For both procedures, the loss of LBM appeared to plateau at 6-months post-operatively. The only statistically significant finding between the two procedures was that RYGB resulted in an additional 0.06 kg loss compared with SG. CONCLUSION: SG and RYGB have been shown to have comparable weight loss and body composition changes in the short-to-medium term following surgery. LBM reduction was most significant in the early post-operative period across the entire cohort.

Improving Hepatocellular Carcinoma Surveillance Outcomes in Patients with Cirrhosis after Hepatitis C Cure: A Modelling Study.

BACKGROUND & AIMS: Hepatocellular carcinoma (HCC) presents a significant global health challenge, particularly among individuals with liver cirrhosis, with hepatitis C (HCV) a major cause. In people with HCV-related cirrhosis, an increased risk of HCC remains after cure. HCC surveillance with six monthly ultrasounds has been shown to improve survival. However, adherence to biannual screening is currently suboptimal. This study aimed to evaluate the effect of increased HCC surveillance uptake and improved ultrasound sensitivity on mortality among people with HCV-related cirrhosis post HCV cure. METHODS: This study utilized mathematical modelling to assess HCC progression, surveillance, diagnosis, and treatment among individuals with cirrhosis who had successfully been treated for HCV. The deterministic compartmental model incorporated Barcelona Clinic Liver Cancer (BCLC) stages to simulate disease progression and diagnosis probabilities in 100 people with cirrhosis who had successfully been treated for hepatitis C over 10 years. Four interventions were modelled to assess their potential for improving life expectancy: realistic improvements to surveillance adherence, optimistic improvements to surveillance adherence, diagnosis sensitivity enhancements, and improved treatment efficacy Results: Realistic adherence improvements resulted in 9.8 (95% CI 7.9, 11.6) life years gained per cohort of 100 over a 10-year intervention period; 17.2 (13.9, 20.3) life years were achieved in optimistic adherence improvements. Diagnosis sensitivity improvements led to a 7.0 (3.6, 13.8) year gain in life years, and treatment improvements improved life years by 9.0 (7.5, 10.3) years. CONCLUSIONS: Regular HCC ultrasound surveillance remains crucial to reduce mortality among people with cured hepatitis C and cirrhosis. Our study highlights that even minor enhancements to adherence to ultrasound surveillance can significantly boost life expectancy across populations more effectively than strategies that increase surveillance sensitivity or treatment efficacy.

Fluorine-18-labelled Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography or Magnetic Resonance Imaging to Diagnose and Localise Prostate Cancer. A Prospective Single-arm Paired Comparison (PEDAL).

BACKGROUND AND OBJECTIVE: Multiparametric magnetic resonance imaging (mpMRI) of the prostate is used for prostate cancer diagnosis. However, mpMRI has lower sensitivity for small tumours. Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) offers increased sensitivity over conventional imaging. This study aims to determine whether the diagnostic accuracy of 18F-DCFPyL PSMA-PET/CT was superior to that of mpMRI for detecting prostate cancer (PCa) at biopsy. METHODS: Between 2020 and 2021, a prospective multicentre single-arm phase 3 imaging trial enrolled patients with clinical suspicion for PCa to have both mpMRI and PSMA-PET/CT (thorax to thigh), with reviewers blinded to the results of other imaging. Multiparametric MRI was considered positive for Prostate Imaging Reporting and Data System (PIRADS) 3-5. PSMA-PET/CT was assessed quantitatively (positive maximum standardised uptake value [SUVmax] >7) and qualitatively (five-point lexicon of certainty). Patients underwent targeted and systematic biopsy, with the technique at the discretion of the treating urologist. Clinically significant PCa (csPCa) was defined as International Society of Urological Pathology grade group (GG) ≥2. The primary outcome was the diagnostic accuracy for detecting PCa, reported as sensitivity, specificity, negative predictive value (NPV), and area under the curve (AUC) of the receiver operating curve. The secondary endpoints included a comparison of the diagnostic accuracy for detecting csPCa, assessing gains in combining PMSA-PET/CT with mpMRI to mpMRI alone. KEY FINDINGS AND LIMITATIONS: Of the 236 patients completing both mpMRI and PSMA-PET/CT, 184 (76.7%) had biopsy. Biopsy histology was benign (n = 73), GG 1 (n = 27), and GG ≥2 (n = 84). The diagnostic accuracy of mpMRI for detecting PCa (AUC 0.76; 95% confidence interval [CI] 0.69, 0.82) was higher than that of PSMA-PET/CT (AUC 0.63; 95% CI 0.56, 0.70, p = 0.03). The diagnostic accuracy of mpMRI for detecting csPCa (AUC 0.72; 95% CI 0.67, 0.78) was higher than that of PSMA-PET/CT (AUC 0.62; 95% CI 0.55, 0.69) but not statistically significant (p = 0.27). A combination of PSMA-PET/CT and mpMRI showed excellent sensitivity (98.8%, 95% CI 93.5%, 100%) and NPV (96%, 95% CI 79.6%, 99.9%) over mpMRI alone (86.9% and 80.7%, respectively, p = 0.01). Thirty-two patients (13.6%) had metastatic disease. They tended to be older (68.4 vs 65.1 yr, p = 0.023), and have higher prostate-specific antigen (PSA; median PSA 9.6 vs 6.2ng/ml, p < 0.001) and abnormal prostate on digital rectal examination (78.2% vs 44.1%, p < 0.001). CONCLUSIONS AND CLINICAL IMPLICATIONS: Multiparametric MRI had superior diagnostic accuracy to PSMA-PET/CT for detecting PCa, though the difference is not significant in case of csPCa detection. A combination of mpMRI and PSMA-PET/CT showed improved sensitivity and NPV. PSMA-PET/CT could be considered for diagnostic use in patients unable to have mpMRI or those with concerning clinical features but negative mpMRI. PATIENT SUMMARY: In this trial, we compared the ability of 18F-labelled prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) with that of multiparametric magnetic resonance imaging (mpMRI) to diagnose prostate cancer by biopsy in a prostate-specific antigen screening population. We found that MRI was superior to PSMA to diagnose prostate cancer, though there was no difference in ability to diagnose clinically significant prostate cancer. PSMA-PET/CT could be considered for diagnostic use in patients unable to have mpMRI or those with concerning clinical features but negative mpMRI. Combining MRI with PSMA-PET increases the negative predictive value over MRI alone and may help men avoid invasive prostate biopsy.

Reproducibility and Accuracy of the PRIMARY Score on PSMA PET and of PI-RADS on Multiparametric MRI for Prostate Cancer Diagnosis Within a Real-World Database.

The PRIMARY score is a 5-category scale developed to identify clinically significant intraprostate malignancy (csPCa) on 68Ga-prostate-specific membrane antigen (PSMA)-11 PET/CT (68Ga-PSMA PET) using a combination of anatomic site, pattern, and intensity. Developed within the PRIMARY trial, the score requires evaluation in external datasets. This study aimed to assess the reproducibility and diagnostic accuracy of the PRIMARY score in a cohort of patients who underwent multiparametric MRI (mpMRI) and 68Ga-PSMA PET before prostate biopsy for the diagnosis of prostate cancer. Methods: In total, data from 242 men who had undergone 68Ga-PSMA PET and mpMRI before transperineal prostate biopsy were available for this ethics-approved retrospective study. 68Ga-PSMA PET and mpMRI data were centrally collated in a cloud-based deidentified image database. Six experienced prostate-focused nuclear medicine specialists were trained (1 h) in applying the PRIMARY score with 30 sample images. Six radiologists experienced in prostate mpMRI read images as per the Prostate Imaging-Reporting and Data System (PI-RADS), version 2.1. All images were read (with masking of clinical information) at least twice, with discordant findings sent to a masked third (or fourth) reader as necessary. Cohen κ was determined for both imaging scales as 5 categories and then collapsed to binary (negative and positive) categories (score 1 or 2 vs. 3, 4, or 5). Diagnostic performance parameters were calculated, with an International Society of Urological Pathology grade group of at least 2 (csPCa) on biopsy defined as the gold standard. Combined-imaging-positive results were defined as any PI-RADS score of 4 or 5 or as a PI-RADS score of 1-3 with a PRIMARY score of 3-5. Results: In total, 227 patients with histopathology, 68Ga-PSMA PET, and mpMRI imaging before prostate biopsy were included; 33% had no csPCa, and 67% had csPCa. Overall interrater reliability was higher for the PRIMARY scale (κ = 0.70) than for PI-RADS (κ = 0.58) when assessed as a binary category (benign vs. malignant). This was similar for all 5 categories (κ = 0.65 vs. 0.48). Diagnostic performance to detect csPCa was comparable between PSMA PET and mpMRI (sensitivity, 86% vs. 89%; specificity, 76% vs. 74%; positive predictive value, 88% vs. 88%; negative predictive value, 72% vs. 76%). Using combined imaging, sensitivity was 94%, specificity was 68%, positive predictive value was 86%, and negative predictive value was 85%. Conclusion: The PRIMARY score applied by first-user nuclear medicine specialists showed substantial interrater reproducibility, exceeding that of PI-RADS applied by mpMRI-experienced radiologists. Diagnostic performance was similar between the 2 modalities. The PRIMARY score should be considered when interpreting intraprostatic PSMA PET images.