RecruitingNot ApplicableNCT07357259

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

244 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 30 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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).

Interventions

DIAGNOSTIC_TESTIntervention Group

Matching of delayed PET images with the standard CT scan


Locations(1)

IRCCS - Policlinico Universitario di Sant'Orsola

Bologna, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07357259


Related Trials