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

Assistance Publique Hopitaux De Marseille

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Kidney Cancers

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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,

Time frame: 1 month