Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial.

IMPORTANCE: In retrospective studies, 68Ga-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging. OBJECTIVE: To assess 68Ga-PSMA-11 PET accuracy in a prospective multicenter trial. DESIGN, SETTING, AND PARTICIPANTS: In this single-arm prospective trial conducted at University of California, San Francisco and University of California, Los Angeles, 635 patients with biochemically recurrent prostate cancer after prostatectomy (n = 262, 41%), radiation therapy (n = 169, 27%), or both (n = 204, 32%) underwent 68Ga-PSMA-11 PET. Presence of prostate cancer was recorded by 3 blinded readers on a per-patient and per-region base. Lesions were validated by histopathologic analysis and a composite reference standard. MAIN OUTCOMES AND MEASURES: Endpoints were positive predictive value (PPV), detection rate, interreader reproducibility, and safety. RESULTS: A total of 635 men were enrolled with a median age of 69 years (range, 44-95 years). On a per-patient basis, PPV was 0.84 (95% CI, 0.75-0.90) by histopathologic validation (primary endpoint, n = 87) and 0.92 (95% CI, 0.88-0.95) by the composite reference standard (n = 217). 68Ga-PSMA-11 PET localized recurrent prostate cancer in 475 of 635 (75%) patients; detection rates significantly increased with prostate-specific antigen (PSA): 38% for <0.5 ng/mL (n = 136), 57% for 0.5 to <1.0 ng/mL (n = 79), 84% for 1.0 to <2.0 ng/mL (n = 89), 86% for 2.0 to <5.0 ng/mL (n = 158), and 97% for ≥5.0 ng/mL (n = 173, P < .001). Interreader reproducibility was substantial (Fleiss κ, 0.65-0.78). There were no serious adverse events associated with 68Ga-PSMA-11 administration. PET-directed focal therapy alone led to a PSA drop of 50% or more in 31 of 39 (80%) patients. CONCLUSIONS AND RELEVANCE: Using blinded reads and independent lesion validation, we establish high PPV for 68Ga-PSMA-11 PET, detection rate and interreader agreement for localization of recurrent prostate cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02940262 and NCT03353740.

Impact of a Bayesian penalized likelihood reconstruction algorithm on image quality in novel digital PET/CT: clinical implications for the assessment of lung tumors.

BACKGROUND: The aim of this study was to evaluate and compare PET image reconstruction algorithms on novel digital silicon photomultiplier PET/CT in patients with newly diagnosed and histopathologically confirmed lung cancer. A total of 45 patients undergoing 18F-FDG PET/CT for initial lung cancer staging were included. PET images were reconstructed using ordered subset expectation maximization (OSEM) with time-of-flight and point spread function modelling as well as Bayesian penalized likelihood reconstruction algorithm (BSREM) with different ß-values yielding a total of 7 datasets per patient. Subjective and objective image assessment with all image datasets was carried out, including subgroup analyses for patients with high dose (> 2.0 MBq/kg) and low dose (≤ 2.0 MBq/kg) of 18F-FDG injection regimen. RESULTS: Subjective image quality ratings were significantly different among all different reconstruction algorithms as well as among BSREM using different ß-values only (both p < 0.001). BSREM with a ß-value of 600 was assigned the highest score for general image quality, image sharpness, and lesion conspicuity. BSREM reconstructions resulted in higher SUVmax of lung tumors compared to OSEM of up to + 28.0% (p < 0.001). BSREM reconstruction resulted in higher signal-/ and contrast-to-background ratios of lung tumor and higher signal-/ and contrast-to-noise ratio compared to OSEM up to a ß-value of 800. Lower ß-values (BSREM450) resulted in the best image quality for high dose 18F-FDG injections, whereas higher ß-values (BSREM600) lead to the best image quality in low dose 18F-FDG PET/CT (p < 0.05). CONCLUSIONS: BSREM reconstruction algorithm used in digital detector PET leads to significant increases of lung tumor SUVmax, signal-to-background ratio, and signal-to-noise ratio, which translates into a higher image quality, tumor conspicuity, and image sharpness.

Validation of CT attenuation correction for high-speed myocardial perfusion imaging using a novel cadmium-zinc-telluride detector technique.

UNLABELLED: The aim of this study was to validate attenuation correction (AC) using low-dose standard CT for myocardial perfusion imaging (MPI) on a novel ultra fast γ-camera with cadmium-zinc-telluride (CZT) detector technology. METHODS: Sixty-six patients (body mass index ± SD, 27.2 ± 3.5 kg/m(2); range, 19.1-36.0 kg/m(2)) underwent a 1-d (99m)Tc-tetrofosmin adenosine stress-rest imaging protocol with 15-min acquisitions on a standard dual-head SPECT camera. All scans were repeated within minutes on the CZT camera, with 3-min acquisitions for stress (low dose) and 2-min acquisitions for rest (high dose) as recently established. We compared maximum myocardial uptake (20-segment model) from CZT versus standard SPECT MPI by intraclass correlation without and with CT AC. In addition, clinical agreement for each coronary territory for all scans from both devices was assessed, and Bland-Altmann (BA) limits of agreement for percentage uptake were calculated. RESULTS: The clinical agreement between CZT and standard SPECT cameras was 96% for noncorrected low- and high-dose images (r = 0.90 and BA = -18 to 15, and r = 0.91 and BA = -15 to 16, respectively), and agreement after AC was 96% for low- and 99% for high-dose images (r = 0.87 and BA = -16 to 14, and r = 0.88 and BA = -16 to 14, respectively). CONCLUSION: Our results support that AC of MPI on the novel CZT camera, compared with AC MPI on a conventional SPECT camera, is feasible because it provides a high correlation of segmental tracer uptake and an excellent clinical agreement.

Myocardial perfusion imaging with real-time respiratory triggering: impact of inspiration breath-hold on left ventricular functional parameters.

BACKGROUND: The latest gamma-camera generation with cadmium-zinc-telluride (CZT) detectors allows myocardial perfusion imaging (MPI) with respiratory triggering at breath-hold. We assessed its impact on functional left ventricular (LV) parameters. METHODS: Twenty-eight consecutive patients underwent a one-day (99m)Tc-tetrofosmin pharmacologic stress/rest imaging protocol on a novel CZT camera. Electrocardiogram-gated high-dose (rest) MPI was performed without and with real-time respiratory triggering by intermittent scanning confined to breath-hold at deep inspiration. We studied the effect of respiratory triggering at deep inspiration levels on LV wall motion, wall thickening, LV volumes and ejection fraction (LVEF) compared to regular MPI without respiratory triggering. RESULTS: Compared to regular MPI without respiratory triggering, systolic and diastolic LV volumes and stroke volumes decreased significantly (P < 0.05) when respiratory triggering was applied. By contrast, there was no significant change in LVEF, with a high correlation (r = .939, P < 0.001) between the two measurements. Furthermore, respiratory triggering introduced a significant change (P < 0.05) in regional LV wall motion. CONCLUSIONS: Respiratory-triggered MPI with breath-hold at deep inspiration levels introduces significant changes to the measured LV volumes, stroke volumes and regional wall motion but does not significantly affect global LVEF when compared to regular MPI with normal breathing.

Nuclear myocardial perfusion imaging with a cadmium-zinc-telluride detector technique: optimized protocol for scan time reduction.

UNLABELLED: We aimed at establishing the optimal scan time for nuclear myocardial perfusion imaging (MPI) on an ultrafast cardiac gamma-camera using a novel cadmium-zinc-telluride (CZT) solid-state detector technology. METHODS: Twenty patients (17 male; BMI range, 21.7-35.5 kg/m(2)) underwent 1-d (99m)Tc-tetrofosmin adenosine stress and rest MPI protocols, each with a 15-min acquisition on a standard dual-detector SPECT camera. All scans were immediately repeated on an ultrafast CZT camera over a 6-min acquisition time and reconstructed from list-mode raw data to obtain scan durations of 1 min, 2 min, etc., up to a maximum of 6 min. For each of the scan durations, the segmental tracer uptake value (percentage of maximum myocardial uptake) from the CZT camera was compared by intraclass correlation with standard SPECT camera data using a 20-segment model, and clinical agreement was assessed per coronary territory. Scan durations above which no further relevant improvement in uptake correlation was found were defined as minimal required scan times, for which Bland-Altman limits of agreement were calculated. RESULTS: Minimal required scan times were 3 min for low dose (r = 0.81; P < 0.001; Bland-Altman, -11.4% to 12.2%) and 2 min for high dose (r = 0.80; P < 0.001; Bland-Altman, -7.6% to 12.9%), yielding a clinical agreement of 95% and 97%, respectively. CONCLUSION: We have established the minimal scan time for a CZT solid-state detector system, which allows 1-d stress/rest MPI with a substantially reduced acquisition time resulting in excellent agreement with regard to uptake and clinical findings, compared with MPI from a standard dual-head SPECT gamma-camera.