82-Rb injection: Injection of 82-Rb for 82-Rb PET imaging
Study summary
This is a pilot prospective longitudinal monocentric, non-comparative, nonrandomised, and non-controlled open study.
is to test whether the intensity of 82-Rb uptake on PET acquisitions is associated to the aggressiveness of RCC on histology (ISUP grades), i.e., to successfully identify high-grade (ISUP grades 3 and 4) vs. lowgrade (ISUP grades 1 and 2) RCC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years old
* Signed written informed consent
* French Social Security affiliation
* Patients with high suspicion of or confirmed RCC requiring surgical resection
* 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)
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria:
* Pregnant or breastfeeding women
* Patient under legal protection (guardianship)
* Contraindication to the PET-CT
* Contraindication to the injection of 82-Rb
* 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
* Patient on SMA (state medical aid)
* Unilateral renal agenesis
* Multicystic renal dysplasia
* Hereditary forms of RCC as VHL, MET, FH and FLCN
* Bosniak 3 cysts
* Hypovascular lesions with enhancement inferior to the renal cortex in corticomedullary-phase images on CTA
* Exclusion of clear renal cell adenocarcinoma on biopsy
* Kidney tumors with high suspicion of extra-renal extension (cT3b, cT3c, cN+ or M+).
Primary outcome measure(s)
Classify the aggressiveness of RCC into low grade and high grade based on the 82-Rb uptake intensity in renal tumors on PET. — Up to three months after surgery Intensity of 82-Rb uptake in the tumor is calculated as the tumor to background ratio (ratio between SUV max in the tumor and the mean SUV in normal renal parenchyma).
High grades are tumors classified as ISUP 3 and 4 on pathology and low grades tumors classified as ISUP 1 and 2 on pathology.
Trial sites (2)
Facility
City
Region
Status
AP-HP - hôpital européen Georges-Pompidou
Paris
France
AP-HP - hôpital européen Georges-Pompidou
Paris
France
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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