Trial results for a study investigating non-contrast perfusion using Arterial Spin Labeled (ASL) MR imaging for therapy response in metastatic Renal Cell Carcinoma were posted on ClinicalTrials.gov on 2025-12-19. The study, which was terminated, enrolled 6 participants.
Background
Renal Cell Carcinoma (RCC) is the most common type of kidney cancer in adults. For patients with metastatic RCC, assessing the effectiveness of therapy is crucial for guiding treatment decisions. Traditional methods often rely on morphological changes, such as tumor size, which may not reflect early treatment response. Non-contrast imaging techniques, like Arterial Spin Labeling (ASL) MR imaging, offer a potential alternative by measuring tissue perfusion without the need for intravenous contrast agents, which can be beneficial for patients with impaired kidney function. This approach aims to provide an earlier and more functional assessment of therapy response.
Trial design
This terminated study, designated as Phase NA, enrolled 6 participants to investigate Renal Cell Carcinoma. The trial aimed to assess non-contrast perfusion using Arterial Spin Labeled (ASL) MR imaging. MRI scans, including ASL, were planned before, during, and after treatment, for a total of up to 6 sessions over 7 months, or until clinical progression. Patients were then to be followed through standard clinical examinations for 3 years or until demise.
Key results
The trial reported key measurements related to the repeatability of perfusion measurement in kidneys from healthy volunteers. No specific quantitative values were provided for the change in perfusion within the tumor itself.
- For healthy volunteers, the repeatability of perfusion measurement in kidneys showed a mean of 306 ml/100g/min (Standard Deviation 60 ml/100g/min).
- Another measurement for healthy volunteers indicated a mean of 283 ml/100g/min (Standard Deviation 56 ml/100g/min) for perfusion in kidneys.
What this means
The posted results offer limited insights into the primary objective of assessing therapy response in metastatic Renal Cell Carcinoma due to the trial's termination and the absence of specific tumor perfusion data. The reported data on the repeatability of perfusion measurements in kidneys from healthy volunteers provides foundational information on the Arterial Spin Labeled (ASL) MR imaging technique itself. This data may be useful for understanding the baseline variability and reliability of ASL perfusion measurements in healthy renal tissue, which could inform the design of future studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04831138, titled "Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma", were posted on 2025-12-19 on clinicaltrials.gov.