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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
Must not have
Subjects may not be receiving any other anti-angiogenic agents, at the time of enrollment
Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently taking any medication that stops the formation of new blood vessels.
Select...
I can undergo an MRI despite my claustrophobia, back pain, or tremors.
Select...
I have sickle cell disease or another condition that causes low red blood cell count.
Select...
I am not pregnant.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in perfusion in the tumor
Progression Free Survival (PFS)
Secondary study objectives
ASL measured perfusion within enhancing tumor
Overall Survival (OS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RCC PatientsExperimental Treatment1 Intervention
Patients with locally advanced or metastatic renal cell carcinoma
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,599 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.
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