Clinical trial · Interventional
Dynamic 82-Rb Positron Emission Tomography (PET) for the Grading of KIDney Carcinoma
NCT07346404CI-TRIAL-00101092RUBIKIDnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 82-Rb injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 82-Rubidium
- description
- 82-Rb; 10 MBq/kg intravenous injection over 30-60 seconds using an automated injection; two injections (Minimal injected activity per injection: 740 MBq ; maximal injected activity per injection: 1480 MBq).
- interventionNames
- Drug: 82-Rb injection
Primary outcomes (1)
- measure
- Classify the aggressiveness of RCC into low grade and high grade based on the 82-Rb uptake intensity in renal tumors on PET.
- timeFrame
- Up to three months after surgery
- description
- 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.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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+).
References
Publications (0)
Data not yet available
No reference posted for this study.