Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07118176

PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Patients With Solid Tumors or Hematologic Cancers

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-08-12

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging tracer called 68Ga-FAPi-46 combined with positron emission tomography (PET) and computed tomography (CT) scans to see how this tracer spreads and accumulates in normal and cancer tissues. The study focuses on patients with various solid tumors or blood cancers, aiming to better understand the tracer's distribution and how it compares to another tracer, 18F-FDG, in detecting different cancer types. This is a phase 1 clinical trial led by the Jonsson Comprehensive Cancer Center. Participants receive an intravenous injection of 68Ga-FAPi-46 and then undergo a PET/CT scan 20 to 90 minutes later, with the scan lasting between 20 and 50 minutes. Some patients may also have an optional PET/CT scan using 18F-FDG for comparison. The PET/CT scan combines images from PET, which detects radioactive tracers, and CT, which provides detailed images of organs and tissues, helping to locate cancer and inflammation. During the study, participants will have their tracer uptake measured and compared using standardized uptake values over a period of up to two years. Researchers will gather data on how 68Ga-FAPi-46 is absorbed in different tissues and how it correlates with 18F-FDG. Participants must be able to stay still during the imaging procedure, and their health and safety will be monitored throughout the trial. This study helps gather important imaging information that may improve cancer detection and diagnosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with suspected or diagnosed cancer types including adrenal, anal, bladder, brain, breast, cancer of unknown primary, cervical, cholangiocarcinoma, colorectal, esophageal, gastric, head and neck, hematologic, hepatocellular, lung, medullary thyroid, neuroendocrine, ovarian, pancreatic, penile, peritoneal, pleural, prostate, sarcoma, salivary gland, solitary fibrous tumor, skin, testicular, thymus, thyroid, urothelial, uterus, and vaginal cancers
  • Patients aged 18 years or older at the time of radiotracer administration
  • Patients able to provide written informed consent
  • Patients able to remain still for up to one hour during the imaging procedure
Not Eligible

You will not qualify if you...

  • Patients who are pregnant or nursing
  • Patients with any underlying disease that might interfere with collecting high-quality imaging data based on investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 day

Participants receive an intravenous injection of 68Ga-FAPi-46 followed by a PET/CT scan to assess the biodistribution of the imaging tracer. An optional 18F-FDG PET/CT scan may also be performed.

1 imaging visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for up to 2 years to evaluate the biodistribution outcomes of the imaging tracers.

Follow-up visits as scheduled

Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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