Status:
TERMINATED
Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Magnetic Resonance Imaging (MRI) including Arterial Spin Labeling (ASL) will be performed before, during, and after the treatment, in a total of up to 6 MRI sessions until 7 months after the first ses...
Detailed Description
The incidence of kidney cancer has steadily increased over the past three to four decades and is among the 10 most frequently diagnosed cancers in the US. Approximately 63,990 new cases of kidney canc...
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic renal cell carcinoma.
- Patients scheduled to undergo anti-angiogenic treatment or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) Status 0, 1 and 2.
- Women of child-bearing potential must agree to undergo a urine pregnancy screening per standard Radiology departmental protocol, in place to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Subjects may not be receiving any other anti-angiogenic agents, at the time of enrollment.
- Subjects must not be pregnant since pregnancy is a contraindication to administration of gadolinium-based contrast agents.
- Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices (e.g. pacemakers, automated implantable cardioverter defibrillators, etc.) and other foreign bodies.
- Known severe allergic reaction to Gadolinium-based contrast agents.
- Patients with sickle cell disease and patients with other hemolytic anemias (low red blood count in body).
- 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.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04831138
Start Date
March 24 2021
End Date
April 4 2023
Last Update
December 19 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390