Dynamic 82-Rb Positron Emission Tomography (PET) for the Grading of KIDney Carcinoma

NCT07346404 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP2314422024-514085-39-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; Positron Emission Tomography; Rubidium-82; neovascularization

Outcome Measures

Primary Outcomes (1)

• Classify the aggressiveness of RCC into low grade and high grade based on the 82-Rb uptake intensity in renal tumors on PET.

  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.

  Up to three months after surgery

Secondary Outcomes (7)

• Correlation between the renal perfusion flow and the degree of neoangiogenesis in the tumor.

  Up to three months after surgery

• Association between imaging biomarkers on 82-Rb-PET and the histological type of the tumor.

  Up to three months after surgery

• Association between imaging biomarkers on 82-Rb-PET and tumor aggressiveness (ISUP grades) in patients with clear-cell renal adenocarcinomas.

  Up to three months after surgery

• Correlation between 82-Rb uptake and the degree of neoangiogenesis in the tumor.

  Up to three months after surgery

• Correlation between the estimated residual renal function and the observed renal function change.

  Up to three months after surgery

Study Arms (1)

82-Rubidium

OTHER

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).

Drug: 82-Rb injection

Interventions

82-Rb injection DRUG

Injection of 82-Rb for 82-Rb PET imaging

82-Rubidium

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women
• Patient under legal protection (guardianship)
• Contraindication to the PET-CT
• Contraindication to the injection of 82-Rb
• 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
• Kidney tumors with high suspicion of extra-renal extension (cT3b, cT3c, cN+ or M+).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Naogen Pharma: collaborator

Study Sites (2)

AP-HP - hôpital européen Georges-Pompidou

Paris, France

Location

AP-HP - hôpital européen Georges-Pompidou

Paris, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neovascularization, Pathologic

Interventions

Rubidium-82

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc-Olivier TIMSIT

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Fabrien HYAFIL

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touria AL AAMRI

CONTACT

+33 1 40 27 18 48; touria.el-aamri@aphp.fr

Liliane HAMMANI-BERKANI

CONTACT

+33 1 56 09 37 62; liliane.berkani@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (2)