The CONFIRM trial protocol: the utility of prostate-specific membrane antigen positron emission tomography/computed tomography in active surveillance for prostate cancer.

OBJECTIVES: Primary objectives: To determine the additive value of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in the risk stratification of men with newly diagnosed prostate cancer (PCa) who would have otherwise been deemed suitable for active surveillance (AS). Specifically, we aim to determine if PSMA PET/CT can detect a cohort of men on AS that are in fact high risk and likely to experience unfavourable outcomes should they remain on their current treatment pathway. SECONDARY OBJECTIVES: to determine the additive value of PSMA PET/CT to repeat multiparametric magnetic resonance imaging (mpMRI) of the prostate and explore whether a confirmatory biopsy may be avoided in men with a negative PSMA PET/CT and a negative repeat mpMRI of the prostate (Prostate Imaging-Reporting and Data System score of <3). Furthermore, to develop a nomogram combining clinical, imaging and biomarker data to predict the likelihood of failure on AS in men with high-risk features. Also, a blood sample will be taken to perform a Prostate Health Index test at the time of confirmatory biopsy. Furthermore, a portion of this blood will be stored at a biobank for up to 5 years if a follow-up study on molecular biomarkers and genetic assays in this cohort of men is indicated, based on the results from the CONFIRM trial. PATIENTS AND METHODS: The CONFIRM trial is a prospective, multicentre, pre-test/post-test, cohort study across Victoria, Australia, involving men with newly diagnosed low-risk PCa with high-risk features, considered suitable for AS and undergoing confirmatory biopsy. The trial's goal is to provide high-quality evidence to establish whether PSMA PET/CT has a role in risk-stratifying men deemed suitable for AS despite having high-risk feature(s). RESULTS: The CONFIRM trial will measure the proportion of men deemed unsuitable for ongoing AS based on pathological upgrading and multidisciplinary team recommendation due to PSMA PET/CT scan and PSMA-targeted confirmatory biopsy. Additionally, the positive and negative predictive values, sensitivity, and specificity of PSMA PET/CT will be calculated in isolation and combined with repeat mpMRI of the prostate. CONCLUSIONS: This trial will provide robust prospective data to determine if PSMA-PET/CT and standard of care (prostate biopsy ± repeat mpMRI) can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features.

Gallbladder lymphoma detected by 18F-fluorodeoxyglucose positron emission tomography.

Gallbladder involvement in lymphoma is rare, with only a few cases reported in the literature, predominately in the pre positron emission tomography (PET) era. 18F-fluorodeoxyglucose (18F-FDG) PET/computed tomography (CT) has now become the modality of choice in the staging of lymphoma. We report a case of gallbladder involvement by high-grade B-cell lymphoma detected by PET/CT.

Prevalence and distribution of functional splenic tissue after splenectomy.

BACKGROUND: Individuals splenectomised for trauma have lower infection rates than those splenectomised for other conditions. Residual functional splenic tissue (FST) after splenectomy may provide ongoing immunological protection. AIMS: To quantify the prevalence and volume of residual FST post-splenectomy using standard testing. METHODS: Splenectomised adults were recruited from the Spleen Australia clinical registry. Eligible individuals had been splenectomised at least 1 year prior to their visit and resided in Victoria. Splenic function was identified by evaluating Howell-Jolly bodies and IgM memory B cells. A 99m-Technetium-labelled, heat-denatured erythrocyte scintigraphic scan was performed if splenic function was detected. RESULTS: Initially, 75 splenectomised individuals (all cause) were recruited, with a median of 58 years of age and who were splenectomised a median of 14 years previously. The most common indications for splenectomy were trauma (30.7%) and haematological disease (28.0%). Scintigraphy identified FST in nine individuals (12.0%). Eight had been splenectomised for trauma. In this cohort, 34.8% of individuals splenectomised for trauma had residual FST. To explore our findings further, 45 additional individuals were recruited, predominately individuals splenectomised for trauma. Twenty-five individuals completed assessments by December 2018. An additional 11 individuals had FST, of whom 9 had been splenectomised for trauma. Overall, we identified 20 individuals with residual FST. Volumes ranged from 2.2 to 216.0 cc. We saw individuals with accessory spleens and splenotic nodules and an individual with both. Seventeen individuals had been splenectomised for trauma. CONCLUSIONS: Residual FST is commonly seen in individuals splenectomised for trauma. It can present in varying distributions and of varying volume. The clinical significance is unclear.

Prevalence of non 18 F-fluorodeoxyglucose-avid incidental findings of clinical significance on whole body positron emission tomography/computed tomography: A review of 500 consecutive cases.

INTRODUCTION: The prevalence of incidental 18 F-fluorodeoxyglucose (FDG)-avid findings on positron emission tomography-computed tomography (PET/CT) has been extensively described. Few studies, however, have assessed the prevalence and significance of non-FDG-avid findings; pathology that is identified on review of the low-dose, non-contrast CT. The aim of this study was to determine the overall prevalence of non FDG-avid incidental findings on PET/CT and the prevalence of 'clinically significant' non FDG-avid pathology. METHODS: Five hundred consecutive whole body PET/CT studies performed in 2016 at a university affiliated tertiary hospital were retrospectively reviewed by two radiologists experienced in reporting PET/CT. Findings were categorized according to potential clinical relevance, and a targeted follow-up of clinically significant incidental findings was performed. RESULTS: Incidental findings were encountered in 463 of 500 (92.6%) patients. In 226 patients, these findings had been detected on previous imaging studies, with unknown incidental findings present in 237 of 500 (47.4%) patients. 113 of 500 (22.6%) patients had non-avid incidental findings of potentially major clinical significance, and in 35 patients (7.0%) these findings were considered previously unknown. The most common non-avid findings of potentially major significance were pulmonary nodules (6 mm or larger), moderate or large size pleural effusions, and vascular aneurysms. Unknown incidental findings of potentially major clinical significance were significantly higher in patients imaged for melanoma staging (P= 0.004). CONCLUSION: The prevalence of incidental findings of clinical significance that do not accumulate FDG in PET/CT is not insignificant. Routine systematic review of the low-dose CT is required to avoid missing potentially clinically important findings, in particular pleural effusions, vascular aneurysms and metastatic pulmonary nodules.