Table of Contents
- Trial overview
- Who can participate
- What is being measured
- Study phase and design
- Why this study matters
Trial overview
The study titled RUBIKID is an interventional trial of RUBIDIUM CHLORIDE in people with kidney carcinoma.[1] It is designed to test whether dynamic 82-Rb positron emission tomography (PET) can help grade kidney cancer more accurately.[1]
The trial is currently Authorised and is planned for 60 participants.[1] The condition being studied is kidney carcinoma, also called RCC in the study summary.[1]
Who can participate
The source data shows that the target population is people with kidney carcinoma.[1] No extra details are given in the source about age limits, prior treatment, or other entry rules.[1]
This means the main group of interest is patients whose kidney tumor can be evaluated with PET imaging and later compared with the tumor’s histology, which means how the cells look under the microscope.[1]
What is being measured
The main outcome is the intensity of 82-Rb uptake in the tumor, calculated as the tumor-to-background ratio.[1] In simple terms, this compares the signal in the tumor with the signal in normal kidney tissue.[1]
The study summary says the trial wants to know whether this PET signal is linked to the aggressiveness of renal cell carcinoma on histology, using ISUP grades.[1] The goal is to identify high-grade tumors, meaning grades 3 and 4, versus low-grade tumors, meaning grades 1 and 2.[1]
The primary outcome uses the SUV max in the tumor and the mean SUV in normal renal parenchyma.[1] SUV max is the highest signal value seen in the tumor, while normal renal parenchyma means healthy kidney tissue.[1]
Study phase and design
This is a Phase 2 study.[1] Phase 2 trials usually look more closely at whether a method works well in a specific patient group.[1]
The study is interventional, which means the research team gives the planned imaging intervention and then measures the results.[1] In this trial, the intervention listed is RUBIDIUM CHLORIDE given by intravenous administration at 2300 MBq.[1]
Why this study matters
Kidney carcinoma can have different levels of aggressiveness, and the trial is testing whether PET imaging can help show those differences.[1] If the scan signal matches the histology grade, it may help doctors better separate more aggressive tumors from less aggressive ones.[1]
The study does not report treatment benefit in the source data; instead, it focuses on diagnostic performance, meaning how well the scan reflects the tumor’s true grade.[1] That makes this trial mainly a research study about imaging and tumor classification, not a treatment study.[1]
