Rubidium chloride for Kidney carcinoma | Renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- French Social Security affiliation"}
• {"criterion_text":"- Patients with high suspicion of or confirmed RCC requiring surgical resection"}
• {"criterion_text":"- Kidney tumor diameter between 2 cm and 7 cm with clear cell imaging feature (hyper vascular lesion with contrast-enhancement similar to the renal cortex on CTA)"}
• {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Patient under legal protection (guardianship)"}
• {"criterion_text":"- Contraindication to the PET-CT"}
• {"criterion_text":"- Contraindication to the injection of 82-Rb"}
• {"criterion_text":"- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable"}
• {"criterion_text":"- Patient on SMA (state medical aid)"}
• {"criterion_text":"- Unilateral renal agenesis"}
• {"criterion_text":"- Multicystic renal dysplasia"}
• {"criterion_text":"- Hereditary forms of RCC as VHL, MET, FH and FLCN"}
• {"criterion_text":"- Bosniak 3 cysts"}
• {"criterion_text":"- Hypovascular lesions with enhancement inferior to the renal cortex in corticomedullary-phase images on CTA"}
• {"criterion_text":"- Exclusion of clear renal cell adenocarcinoma on biopsy"}
• {"criterion_text":"- Kidney tumors with high suspicion of extra-renal extension (cT3b, cT3c, cN+ or M+)."}

Primary endpoints

• {"endpoint_text":"- Intensity of 82-Rb uptake in the tumor calculated as the tumor to background ratio (ratio between SUV max in the tumor and the mean SUV in normal renal parenchyma).","definition_or_measurement_approach":"Intensity of 82-Rb uptake in the tumor calculated as the tumor to background ratio (ratio between SUV max in the tumor and the mean SUV in normal renal parenchyma)."}

Secondary endpoints

• {"endpoint_text":"- Renal perfusion flow measured on 82-Rb-PET and the degree of neoangiogenesis in the tumor.","definition_or_measurement_approach":"Renal perfusion flow measured on 82-Rb-PET and the degree of neoangiogenesis in the tumor."}
• {"endpoint_text":"- Imaging biomarkers on 82-Rb-PET and the histological type of the tumor","definition_or_measurement_approach":"Imaging biomarkers on 82-Rb-PET (e.g., maximal tumoral 82-Rb uptake (K1), ratios, standard deviations) correlated with histological tumor type."}
• {"endpoint_text":"- Imaging biomarkers on 82-Rb-PET and tumor aggressiveness (ISUP grades) in patients with clear-cell renal adenocarcinomas.","definition_or_measurement_approach":"Association between imaging biomarkers from dynamic 82-Rb-PET and ISUP histological grades (identification of high-grade ISUP 3-4 vs low-grade ISUP 1-2)."}
• {"endpoint_text":"- Rubidium uptake measured on 82-Rb-PET and degree of tumor vascularization measured on immuno-histology (CD34 and VEGF immunostaining).","definition_or_measurement_approach":"Correlation of 82-Rb uptake on PET with immunohistology markers of vascularization (CD34, VEGF)."}
• {"endpoint_text":"- Estimated residual renal function based on 82-Rb-PET and change of creatinine clearance between baseline and three months after surgery.","definition_or_measurement_approach":"Estimate of residual renal function from 82-Rb-PET compared with observed change in creatinine clearance from baseline to 3 months post-surgery."}
• {"endpoint_text":"- Percentage of patients reclassified according to the gold-standard (ISUP grade of clear-cell renal adenocarcinomas on pathology).","definition_or_measurement_approach":"Proportion of patients whose grade classification changes when comparing 82-Rb-PET (or biopsy) results to final surgical pathology (ISUP grade)."}
• {"endpoint_text":"- The serious adverse events (SAE) related to 82-Rb","definition_or_measurement_approach":"Recording and reporting of serious adverse events judged related to 82-Rb administration."}

France

Earliest CTIS Part Ii Submission Date

16-07-2025

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

21

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France