Evaluation of 68Ga-PSMA PET-CT in the Initial Staging of Advanced Renal Cell Carcinomas - A Prospective, Multicentre, Open-label Study (REIN-TEP PSMA)

May 28, 2026 updated by: Assistance Publique Hopitaux De Marseille
Kidney cancer in adults is the seventh leading cause of cancer-related death in France. Early and accurate imaging of the primary tumour and the identification of metastatic sites are major prognostic factors that are crucial for determining the appropriate stage-specific treatment. However, the diagnosis of sub-centimetre metastatic lymph nodes and occult metastatic lesions remains difficult with current imaging methods. Recent publications have shown promising results for 68Ga-PSMA PET-CT in the detection of metastases from renal cell carcinoma (RCC). It is therefore necessary to develop a new, more sensitive and specific imaging method to detect occult metastatic foci, enabling the earlier initiation of specific systemic or local treatment, and thereby improving survival in these patients or even achieving prolonged remission in oligometastatic cases Experience and acceptability of a new organisational model in primary care: participatory multi-professional health centres

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years, enrolled in a social security scheme.
  • Signed informed consent form.
  • Patient newly diagnosed with localised intermediate- or high-risk renal cell carcinoma (UISS prognostic system) or metastatic renal cancer (M1 according to TNM staging) with histological evidence (biopsy or surgical specimen).
  • Recent conventional imaging work-up (dated no more than 1 month prior to the 68Ga-PSMA PET scan):
  • Brain CT, chest and abdominal-pelvic CT with iodine injection, including arterial, portal and late phases;
  • Bone scan (BS);

Exclusion Criteria:

  • Pregnant or breastfeeding women;
  • History of another known progressive neoplasm within the past two years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEP-TDM au 68Ga-PSMA
A 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations
Diagnostic test: 68Ga-PSMA PET-CT scan
A 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
classification of the lesion as 'malignant' or 'benign'
Time Frame: 1 month

The value of 68Ga-PSMA PET-CT will be determined by the number of patients for whom:

  • at least one lesion classified as 'malignant' on PET is not visible or is classified as 'benign' on the reference imaging, or
  • at least one lesion classified as 'malignant' by the reference imaging is ruled out (classified as 'benign') on PET.

The 'malignant'/'benign' classification of the lesion is based on 68Ga-PSMA PET-CT and on the reference imaging,
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2020

Primary Completion (Estimated)

February 1, 2022

Study Completion (Estimated)

February 1, 2022

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-003760-47 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

study withdrawned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe