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ASL-MRI for Kidney Cancer
N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with locally advanced or metastatic renal cell carcinoma
Patients scheduled to undergo anti-angiogenic treatment or immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will use MRI to track changes in the tumor before, during, and after treatment in up to 6 sessions, scheduled around the patient's clinical imaging sessions.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There are generally no side effects associated with undergoing an MRI itself; however, the process might be uncomfortable due to its duration and the need to remain still. There's also a small risk related to allergic reactions from any potential use of Gadolinium-based contrast agent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer has spread beyond the kidney.
Select...
I am scheduled for treatment that stops tumors from making new blood vessels or boosts my immune system.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in perfusion in the tumor
Progression Free Survival (PFS)
Secondary outcome measures
ASL measured perfusion within enhancing tumor
Overall Survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: RCC PatientsExperimental Treatment1 Intervention
Patients with locally advanced or metastatic renal cell carcinoma
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,050 Previous Clinical Trials
1,054,269 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You cannot have an MRI because you have certain medical devices or objects in your body that are not safe for an MRI.I can undergo an MRI despite my claustrophobia, back pain, or tremors.I am a woman who can become pregnant and agree to a pregnancy test before imaging.I have sickle cell disease or another condition that causes low red blood cell count.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: RCC Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study actively seeking participants at the moment?
"According to information posted on clinicaltrials.gov, this study is currently recruiting participants with the original post date being March 24th 2021 and most recent update occurring April 1st 2022."
Answered by AI
How many participants are included in this trial?
"Affirmative, the information on clinicaltrials.gov states that this research protocol is actively recruiting participants. First posted in March 2021 and last modified in April 2022, 90 individuals are required to participate at a single medical centre."
Answered by AI
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