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NCT05079828Completed

Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007

Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 for the Detection of Recurrent Prostate Cancer in PSMA-ligand PET/CT

Source: ClinicalTrials.gov · Last updated 10 Dec 2024

Brief summary (registry, in English)

The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.

Status (registry)
Completed
Study type
Interventional
Enrollment
100 (actual)
First submitted
13 Jul 2021
Start date
7 Jul 2022
Primary completion date
1 May 2024
Lead sponsor
Insel Gruppe AG, University Hospital Bern
NCT number
NCT05079828

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 7 Jul 2022 to the primary completion date, 1 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving androgen deprivation therapy (ADT) within 6 months prior to the PSMA-PET/CT

Other illness

  • Patients undergoing active treatment for a second non-prostatic malignancy at the time of the first scan.
  • Known sensitivity or allergy to PSMA-ligands or one of the components of the radiotracer solutions used.

Lab values

  • Patients with renal dialysis or relevant renal impairment (eGFR \< 35 ml/min)

Other

  • Patients with contraindication to diuresis with 20mg Furosemide
  • Inability to provide written informed consent
  • Inability to schedule and attend two consecutive PET examinations

Who the study is looking for

  • Patients with known biochemical recurrence of a histologically confirmed prostate cancer post radical prostatectomy, defined as two consecutive prostate specific antigen (PSA) values \> 0.2 ng/ml:
  • Post prostatectomy: Patients \> 18 y/o
  • PSA measured within ± 4 weeks of the first PSMA-PET/CT
  • Patients providing written informed consent
  • No change in PC treatment in the period between the first and second scans

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inselspital Universitätsspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.