Status:
NOT_YET_RECRUITING
Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients
Lead Sponsor:
Eben Rosenthal
Collaborating Sponsors:
Vanderbilt University Medical Center
Vanderbilt-Ingram Cancer Center
Conditions:
Solid Tumor Cancer
Solid Tumor Malignancy
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief Summary
This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 par...
Detailed Description
This is a pilot study to compare PET/CT uptake of 68Ga-FAPI-46 to uptake parameters determined by Standard of Care MRI or CT with contrast. Patients with a solid tumor diagnosis who are scheduled to u...
Eligibility Criteria
Inclusion
- Age ≥ 19 years.
- Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
- Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
- Have acceptable kidney function and clinical lab values.
Exclusion
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- Females who are currently pregnant or breastfeeding
- Severe renal disease or anuria
- Inability to lie flat or remain still for the duration of the scan.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06922825
Start Date
November 1 2025
End Date
September 1 2032
Last Update
August 6 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232