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

January 7, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tumoral vascularization is an important prognostic marker in renal cell carcinomas (RCC). The evaluation of RCC is often complex before surgery as only a small peripheral segment of the tumor is obtained with biopsy and tend to underestimate the aggressiveness and grade of RCC. Accurate noninvasive evaluation of the aggressiveness of RCC could improve the characterization of tumors before surgery and help guide patient management. Radiolabeled water has demonstrated its interest for the quantification of the vascularization of renal tumors in Positron Emission Tomography (PET). The synthesis of radiolabeled water requires, however, an on-site cyclotron, which is available only in a limited number of hospitals. 82-Rb, a potassium analog and positron-emitting radiotracer, is taken up by myocardial and renal cells. 82-Rb has been used for more than 15 years in North America for the quantification of myocardial perfusion with PET. The solution of 82-Rb chloride is obtained from 82-Sr / 82-Rb radiopharmaceutical generators which have recently obtained a marketing authorization in Europe. These generators can be installed in nuclear medicine departments in hospitals. Myocardial perfusion flow can be precisely quantified by modelling tissue uptake of the tracer on dynamic acquisitions obtained during the intravenous administration of 82-Rb chloride. Our hypothesis is that 82-Rb uptake profile could help grade noninvasively the aggressiveness of renal tumors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • AP-HP - hôpital européen Georges-Pompidou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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+).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 82-Rubidium
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
Injection of 82-Rb for 82-Rb PET imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Classify the aggressiveness of RCC into low grade and high grade based on the 82-Rb uptake intensity in renal tumors on PET.
Time Frame: 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.
Up to three months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between the renal perfusion flow and the degree of neoangiogenesis in the tumor.
Time Frame: Up to three months after surgery

The renal perfusion flow is measured on 82-Rb-PET. It is the maximum tumor flux, measured in tumors and expressed as ml/mn/g.

The degree of neoangiogenesis is the degree of tumor vascularization measured on immuno-histology (CD34 and VEGF immunostaining). This degree for CD34 is calculated as the maximum density among four regions for CD34. The same applies to VEGF.
Up to three months after surgery
Association between imaging biomarkers on 82-Rb-PET and the histological type of the tumor.
Time Frame: Up to three months after surgery
The imaging biomarkers are: 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 the 82-Rb-PET acquisitions.
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.
Time Frame: Up to three months after surgery
Imaging biomarkers are: 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 the 82-Rb-PET acquisitions.
Up to three months after surgery
Correlation between 82-Rb uptake and the degree of neoangiogenesis in the tumor.
Time Frame: Up to three months after surgery
Rubidium uptake measured on 82-Rb-PET and degree of tumor vascularization measured on immuno-histology (CD34 and VEGF immunostaining).
Up to three months after surgery
Correlation between the estimated residual renal function and the observed renal function change.
Time Frame: Up to three months after surgery
Estimated residual renal function based on 82-Rb-PET before surgery and change of creatinine clearance between baseline (the day of the 82-Rb-PET imagine) and three months after surgery.
Up to three months after surgery
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.
Time Frame: Up to three months after surgery
Percentage of patients reclassified according to the gold-standard (ISUP grade of clear-cell renal adenocarcinomas on pathology).
Up to three months after surgery
Safety and tolerance of 82-Rb
Time Frame: Up to 72 hours after the PET with injection of the radiopharmaceutical
Serious adverse events related to 82-Rb.
Up to 72 hours after the PET with injection of the radiopharmaceutical

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Naogen Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc-Olivier TIMSIT, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Fabrien HYAFIL, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP231442
  • 2024-514085-39-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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