Skip to content

Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.

Delayed Pelvic Imaging With [68]Ga-PSMA PET/CT in a Patient With High-risk Prostate Cancer.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07357259
Acronym
SPIR202302
Enrollment
244
Registered
2026-01-21
Start date
2025-02-03
Completion date
2027-03-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Prostate Cancer

Keywords

PET/CT, [68]Ga - PSMA, Delay CT scan, Radiation Dose Optimization

Brief summary

Recent evidence suggests that both standard-time and delayed-time \[⁶⁸Ga\]Ga-PSMA PET acquisitions can reveal clinically relevant findings, and neither phase should be excluded a priori in routine practice. This study evaluates a streamlined dual-phase protocol consisting of: * A standard whole-body PET/CT acquisition performed 60 minutes after radiotracer administration. * A delayed pelvic PET-only acquisition performed 90 minutes post-injection, reconstructed using the attenuation-correction CT (CT/AC) obtained from the initial whole-body scan. Because the prostate gland and pelvic lymph nodes exhibit minimal physiological mobility, accurate PET-CT anatomical correspondence can be maintained through careful patient repositioning, without repeating the CT scan. The main advantage of this protocol is a reduction in patient radiation exposure, as the delayed phase does not require a second CT scan. It also reduces in-department time and maintains diagnostic quality of PET interpretation, provided that the PET-CT alignment remains acceptable. This method may additionally enhance workflow efficiency in the Nuclear Medicine Unit by allowing early identification-based on predefined clinical parameters-of patients most likely to benefit from delayed pelvic imaging.

Detailed description

This study evaluates a modified dual-phase \[⁶⁸Ga\]Ga-PSMA PET/CT protocol designed to reduce radiation exposure and streamline workflow while maintaining diagnostic quality in the assessment of prostate cancer. Conventional imaging often includes a standard whole-body PET/CT acquisition at approximately 60 minutes post-injection followed by a delayed pelvic PET/CT, which can provide additional lesion detectability but requires a second CT scan. The additional CT increases both radiation dose and examination duration. The proposed protocol replaces the delayed CT with a PET-only pelvic acquisition performed 90 minutes post-injection. Delayed PET images are reconstructed and attenuation-corrected using the CT dataset obtained during the initial whole-body acquisition. This approach is feasible because pelvic structures relevant to prostate cancer-such as the prostate gland and pelvic lymph nodes-exhibit limited physiological motion compared with intraperitoneal organs, allowing reliable PET-CT anatomical correspondence through optimized patient repositioning. The study adopts a randomized, two-arm design including patients undergoing staging for newly diagnosed prostate cancer or evaluation of biochemical recurrence. Randomization is stratified by prior radical prostatectomy to account for potential anatomical variability. The control arm follows the standard clinical workflow with both standard and delayed PET/CT acquisitions. The intervention arm undergoes standard whole-body PET/CT at 60 minutes and delayed PET-only imaging at 90 minutes. Anatomical matching between delayed PET images and the CT dataset will be independently evaluated by three Medical Imaging Technologists (TSRM1, TSRM2, TSRM3) across three blinded reading sessions. Each rater will score image alignment using a standardized 1-5 Likert scale. The primary endpoint is the quality of PET-CT matching, assessed through Fleiss' kappa statistics to quantify interrater agreement and compare matching performance between the two imaging workflows. Secondary objectives examine the potential reduction in radiation exposure, measured through CTDIvol and DLP values obtained from the CT Dose Report, and the impact on patient experience and departmental efficiency. Patient-perceived waiting time and comfort will be assessed through a short questionnaire administered after the examination, while objective in-department duration will be extracted from institutional scheduling records. If effective, the streamlined protocol may support broader adoption of CT-free delayed pelvic imaging by demonstrating that optimized technologist-led positioning can maintain diagnostic interpretability while improving patient-centered outcomes and reducing overall radiation burden.

Interventions

DIAGNOSTIC_TESTIntervention Group

Matching of delayed PET images with the standard CT scan

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed prostate cancer undergoing staging, or * Biochemical recurrence following prior radical-intent therapy (surgery and/or radiotherapy), or * High-risk prostate cancer, defined as Gleason Score ≥ 8 or PSA ≥ 20 ng/mL. * Written informed consent and authorization for personal data processing.

Exclusion criteria

* Genitourinary comorbidities that could interfere with imaging or interpretation. * Intermediate- or low-risk prostate cancer. * Delayed acquisition performed on a PET/CT scanner different from the standard acquisition. * Additional PET/CT required due to artifacts compromising diagnostic quality (e.g., urinary retention, excessive motion). * Patients previously enrolled who require repeat PET/CT as a new visit. * Inability to provide informed consent or impaired decision-making capacity. * Known hypersensitivity to the radiopharmaceutical or its components. * Contraindications to PET/CT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).

Design outcomes

Primary

MeasureTime frameDescription
Matching Quality of Delayed PET with Standard CTUp to completion of the study, on average 1 year.Evaluation of the actual matching accuracy between delayed PET images-reconstructed and attenuation-corrected using the dedicated CT/AC dataset-and the standard CT scan within the new procedural approach to \[68\]Ga-PSMA PET/CT. Three Technologist of Medical Imaging (TSRM1, TSRM2, TSRM3) will evaluate the images independently, in a blinded manner, at three separate time points (t1, t2, t3). The registration accuracy between delayed PET images and the standard CT scan will be evaluated using a qualitative questionnaire based on the evaluators' professional experience (minimum of five years in Nuclear Medicine). Image registration will be scored on a 5-point ordinal scale, ranging from 1 (complete mismatch) to 5 (perfect registration). Unit of Measure: 5-point ordinal scale (1-5)

Secondary

MeasureTime frameDescription
Radiation Dose OptimizationUp to completion of study, on average 1 year.Change in CTDIvol (Computed Tomography Dose Index volume) in the experimental arm. CTDIvol (mGy) will be used to assess changes in radiation dose related to the experimental protocol. Unit of Measure: Milligray (mGy)
Patient Throughput and ExperienceUp to completion of study, on average 1 year.Comparison of patient experience in the Nuclear Medicine Unit between the two study groups. Patient experience will be evaluated using a structured, patient-reported questionnaire at the end of the \[68\]Ga-PSMA PET/CT examination, based on the perceived quality of staff information regarding waiting times. Unit of Measure: \- Patient experience: 5-level ordinal scale (Very poor → Excellent)

Countries

Italy

Contacts

CONTACTMichela Moscarino, Technician
michela.moscarino@aosp.bo.it+390512143179
PRINCIPAL_INVESTIGATORMichela Moscarino, Technician

IRCCS Università di Bologna, Policlinico di Sant'Orsola

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026