ASL-MRI for Kidney Cancer

Overseen By Ananth Madhuranthakam, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Anti-angiogenics, Immunotherapy

Must not be taking: Anti-angiogenics

Disqualifiers: Pregnancy, MRI contraindications, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special type of MRI, called Arterial Spin Labeling (ASL), can track changes in kidney cancer before, during, and after treatment. Researchers aim to determine if this imaging can reveal changes in the cancer earlier than standard scans that focus on size. The trial includes several MRI sessions to monitor these changes over time. It suits individuals with advanced kidney cancer who are about to begin specific cancer treatments and can undergo MRI procedures without issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative imaging research that could enhance cancer treatment monitoring.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other anti-angiogenic agents when you enroll.

What prior data suggests that this MRI technique is safe for kidney cancer patients?

Research has shown that using MRI with ASL (Arterial Spin Labeling) is generally safe for patients. MRI is a common imaging method that uses magnets and radio waves to capture images inside the body. ASL is a special technique that measures blood flow without requiring a contrast dye. Studies indicate that ASL's safety is comparable to that of a regular MRI, meaning there are no additional risks compared to a standard MRI scan.

Previous studies reported no significant adverse events with ASL MRI, suggesting it is well-tolerated. Therefore, for those considering joining this study, the ASL MRI component should be as safe as a typical MRI scan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ASL-MRI for kidney cancer because it offers a new way to assess blood flow in tumors without the need for contrast agents, which are typically required in standard imaging techniques. Traditional treatments for renal cell carcinoma often rely on surgery, targeted therapy, and immunotherapy, but monitoring their effectiveness can be challenging. ASL-MRI stands out by providing a non-invasive and safer method to evaluate how well these treatments are working. This technique could improve how doctors track tumor progression and tailor treatments more effectively for individual patients.

What evidence suggests that MRI with ASL is effective for kidney cancer?

Research has shown that a special type of MRI called Arterial Spin Labeling (ASL) can detect changes in kidney tumors early during treatment. In this trial, patients with locally advanced or metastatic renal cell carcinoma will undergo ASL MRI to assess its effectiveness. One study found that ASL MRI helped check blood flow in kidney cancer that had spread, indicating how a tumor responded to treatment. Another study demonstrated that using ASL alongside other imaging methods improved the accuracy of tumor assessment. This suggests that ASL MRI might help doctors evaluate treatment effectiveness before the tumor changes in size. While ASL MRI isn't suitable for all types of kidney cancer, it provides important information about tumor blood flow and treatment progress. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or spreading kidney cancer who are about to start anti-angiogenic treatment or immunotherapy. They must be able to consent, not pregnant, and have an ECOG status of 0-2 (which measures their level of functioning). People can't join if they're on other anti-angiogenic drugs, pregnant, have MRI-incompatible devices in their body, severe allergies to Gadolinium contrast agents, certain blood disorders or conditions that make lying still for an MRI impossible.

Inclusion Criteria

My kidney cancer has spread beyond the kidney.

I am scheduled for treatment that stops tumors from making new blood vessels or boosts my immune system.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You have had a serious allergic reaction to Gadolinium-based contrast agents.

I am not currently taking any medication that stops the formation of new blood vessels.

You cannot have an MRI because you have certain medical devices or objects in your body that are not safe for an MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI sessions including Arterial Spin Labeling (ASL) before, during, and after treatment to assess therapy response

7 months

Up to 6 MRI sessions

Follow-up

Participants are monitored through standard clinical examinations for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI with ASL

Trial Overview

The trial tests how well a type of MRI scan called Arterial Spin Labeling (ASL) can track changes in kidney tumors during treatment. Participants will undergo up to six additional MRIs over seven months plus standard follow-ups for three years. The ASL scans may show changes in tumor blood flow as early as two weeks after starting therapy.

How Is the Trial Designed?

Group I: RCC Patients Experimental Treatment 1 Intervention

Patients with locally advanced or metastatic renal cell carcinoma

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study of 33 renal carcinoma cases, both CT and MRI showed similar accuracy in staging early-stage tumors, correctly staging 27 and 28 tumors respectively.

For advanced renal carcinoma, MRI outperformed CT, particularly in accurately diagnosing tumor thrombus, suggesting that MRI could be a better alternative to conventional cavography for assessing tumor extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The staging of renal-cell carcinomas in MRT and CT--a prospective histologically controlled study]. Hallscheidt, P., Stolte, E., Roeren, T., et al.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7850237/

Arterial Spin Labeled Perfusion MRI for the Evaluation of ...

In this study, we used ASL MRI to assess tumor vascularity of renal cell carcinoma metastases before and during antiangiogenic therapy. The ...

2.

eurradiolexp.springeropen.com

eurradiolexp.springeropen.com/articles/10.1186/s41747-024-00537-y

Exploring the value of arterial spin labeling and six diffusion ...

We found a significant improvement in the diagnostic accuracy and fitting performance compared to using ASL and diffusion models alone in ...

3.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.644975/full

Arterial Spin Labeling MRI for Predicting Microvascular ...

This study aimed to prospectively evaluate the performance of arterial spin labeling (ASL) MRI for predicting MVI of T1 staging ccRCC preoperatively.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11621297/

Exploring the value of arterial spin labeling and six ...

We found a significant improvement in the diagnostic accuracy and fitting performance compared to using ASL and diffusion models alone in ...

5.

qims.amegroups.org

qims.amegroups.org/article/view/2231/html

Initial experience with arterial spin-labeling MR imaging to ...

ASL-MRI was not useful for differentiating between low and high-grade clear cell RCC or between pT1 and pT3 tumors.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8168533/

Arterial Spin Labeling MRI for Predicting Microvascular ...

This study aimed to prospectively evaluate the performance of arterial spin labeling (ASL) MRI for predicting MVI of T1 staging ccRCC preoperatively.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00953446

Arterial Spin Labeling Blood Flow Magnetic Resonance ...

The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track tumor growth for renal cell carcinoma while participants are on ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/B9780323952095000131

Perfusion MRI in the kidneys: Arterial spin labeling

Regarding the data acquisition using ASL sequences, the safety considerations are those that apply to any MRI examination. Since generally ASL sequences have ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04831138

Non-Contrast Perfusion Using Arterial Spin Labeled MR ...

The current 5-year survival rates are estimated at 74% overall, decreasing to 53% among patients with locally advanced diseases. The most common form of kidney ...