Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04831138
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • MRI with ASL — OTHER
    T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement. T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session. T4: MRI with ASL will be performed along with patient's standard of care imaging session. T5: MRI with ASL will be performed along with patient's standard of care imaging session.
  • ASL-MRI — OTHER
    Healthy volunteers - MRI with ASL protocol optimization

Study Details

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 session, or when progression is clinically indicated. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first. Clinically, metastatic renal cell carcinoma (RCC) patients are imaged every 2-3 months after the initiation of anti-angiogenic therapy, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience has shown functional changes including perfusion as early as 2-weeks after the initiation of the treatment. T0, T1, and T2 sessions will be performed for this proposal, while T3, T4, and T5 will be performed along with the clinical imaging sessions. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period. The research MR imaging may take approximately an additional 15 minutes per each imaging session, when done in conjunction with the clinical imaging. The T0, T1, and T2 research MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour.

Key Dates

Start date
Mar 24, 2021
Status verified
Nov 2025
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: RCC Patients
    Patients with locally advanced or metastatic renal cell carcinoma
  • Other: Healthy Volunteers
    Healthy volunteers to optimize protocol

Primary Outcome Measure

Change in Perfusion in the Tumor [ Time Frame: Baseline to 7 and 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Kidney cancer
By specialty
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By research site
UT Southwestern Medical Center· Dallas, TX

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