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

NCT07624578 | Withdrawn

• 1 other identifier: 2019-003760-47
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Kidney Cancers

Keywords

Kidney cancer

Outcome Measures

Primary Outcomes (1)

• classification of the lesion as 'malignant' or 'benign'

  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

Study Arms (1)

TEP-TDM au 68Ga-PSMA

EXPERIMENTAL

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

Interventions

68Ga-PSMA PET-CT scan DIAGNOSTIC_TEST

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

TEP-TDM au 68Ga-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: January 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share