RUBIKID - Dynamic 82-Rb positron emission tomography (PET) for the grading of KIDney carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Mar 2026 → ongoing

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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. low-grade (ISUP grades 1 and 2) RCC.

Secondary objectives 7

1. To study the correlation between the renal perfusion flow measured on 82-Rb-PET and the degree of neoangiogenesis in the tumor at baseline.
2. To measure the association between several imaging biomarkers (maximal tumoral 82-Rb uptake (K1), ratio between maximal tumoral and non-tumoral renal perfusion, ratio between maximal tumoral and non-tumoral Rubidium uptake, standard deviation of perfusion values in the tumor, Standard deviation of 82-Rb uptake in the tumor) calculated from dynamic 82-Rb-PET acquisitions and histological type.
3. To measure the association between several imaging biomarkers (maximal tumoral 82-Rb uptake (K1), ratio between maximal tumoral and non-tumoral renal perfusion, ratio between maximal tumoral and non-tumoral Rubidium uptake, standard deviation of perfusion values in the tumor, Standard deviation of 82-Rb uptake in the tumor) calculated from dynamic 82-Rb-PET acquisitions and aggressiveness of clear-cell renal adenocarcinomas on histology (ISUP grades), i.e., to successfully identify high-grade (ISUP grades 3 and 4) and low-grade (ISUP grades 1 and 2) in patients with clear-cell adenocarcinoma.
4. To study the correlation between 82-Rb uptake measured on PET and the degree of neoangiogenesis in the tumor.
5. To study the correlation between the estimated residual renal function based on 82-Rb-PET before surgery and the observed renal function change at 3 months after surgery.
6. To compare the diagnostic performance of biopsy and 82-Rb-PET for the ISUP grading of clear cell renal adenocarcinomas against the final results of histology (gold standard) of the renal tumor after surgery.
7. To study the safety and tolerance of 82-Rb at baseline.

Conditions and MedDRA coding

Kidney carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 18 years old
2. Signed written informed consent
3. French Social Security affiliation
4. Patients with high suspicion of or confirmed RCC requiring surgical resection
5. 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)
6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion criteria 13

1. Pregnant or breastfeeding women
2. Patient under legal protection (guardianship)
3. Contraindication to the PET-CT
4. Contraindication to the injection of 82-Rb
5. 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
6. Patient on SMA (state medical aid)
7. Unilateral renal agenesis
8. Multicystic renal dysplasia
9. Hereditary forms of RCC as VHL, MET, FH and FLCN
10. Bosniak 3 cysts
11. Hypovascular lesions with enhancement inferior to the renal cortex in corticomedullary-phase images on CTA
12. Exclusion of clear renal cell adenocarcinoma on biopsy
13. Kidney tumors with high suspicion of extra-renal extension (cT3b, cT3c, cN+ or M+).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 7

1. Renal perfusion flow measured on 82-Rb-PET and the degree of neoangiogenesis in the tumor.
2. Imaging biomarkers on 82-Rb-PET and the histological type of the tumor
3. Imaging biomarkers on 82-Rb-PET and tumor aggressiveness (ISUP grades) in patients with clear-cell renal adenocarcinomas.
4. Rubidium uptake measured on 82-Rb-PET and degree of tumor vascularization measured on immuno-histology (CD34 and VEGF immunostaining).
5. Estimated residual renal function based on 82-Rb-PET and change of creatinine clearance between baseline and three months after surgery.
6. Percentage of patients reclassified according to the gold-standard (ISUP grade of clear-cell renal adenocarcinomas on pathology).
7. The serious adverse events (SAE) related to 82-Rb

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Marc-Olivier TIMSIT

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Marc-Olivier TIMSIT

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications