Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07118176
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Fludeoxyglucose F-18 — OTHER
    Given IV
  • Gallium Ga 68 FAPi-46 — RADIATION
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Sep 6, 2026
Completion
Sep 7, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (68Ga-FAPi-46 PET/CT)
    Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.

Primary Outcome Measure

Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Jeremie Calais
[email protected]
310-825-3617
Jeremie Calais (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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