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

NCT04831138 | Terminated Results DMC

• 2 other identifiers: STU 032018-0781U01CA207091-01A1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Cell Carcinoma

Keywords

magnetic resonance imaging; arterial spin labeling

Outcome Measures

Primary Outcomes (1)

• Change in Perfusion in the Tumor

  Measure change in perfusion at 7 days and 14 days compared to baseline measurement.

  Baseline to 7 and 14 days

Secondary Outcomes (1)

• Repeatability of Perfusion Measurement in Kidneys

  Baseline, 2 weeks

Study Arms (2)

RCC Patients

EXPERIMENTAL

Patients with locally advanced or metastatic renal cell carcinoma

Other: MRI with ASL

Healthy Volunteers

OTHER

Healthy volunteers to optimize protocol

Other: ASL-MRI

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.

Also known as: MR Imaging

RCC Patients

ASL-MRI OTHER

Healthy volunteers - MRI with ASL protocol optimization

Also known as: MRI Optimization

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Ananth Madhuranthakam
• Organization: UT Southwestern Medical Center

ananth.madhuranthakam@utsouthwestern.edu

214-648-7737

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: March 24, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-11

Locations

US (1)