Actively Recruiting

Phase Not Applicable
Age: 30Years +
MALE
NCT07357259

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-01-21

244

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed prostate cancer undergoing staging
  • Biochemical recurrence following prior radical-intent therapy (surgery and/or radiotherapy)
  • High-risk prostate cancer, defined as Gleason Score 65 8 or PSA 65 20 ng/mL
  • Written informed consent and authorization for personal data processing
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS - Policlinico Universitario di Sant'Orsola

Bologna, Italy, Italy, 40138

Actively Recruiting

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Research Team

M

Michela Moscarino, Technician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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