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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with the following suspected or diagnosed cancer types: - Adrenal cancer.
  • - Anal cancer.
  • - Bladder cancer.
  • - Brain cancer.
  • - Breast cancer.
  • - Cancer of unknown primary (CUP) - Cervical cancer.
  • - Cholangiocarcinoma.
  • - Colorectal cancer.
  • - Esophageal cancer.
  • - Gastric cancer.
  • - Head and neck cancer.
  • - Hematologic cancer.
  • - Hepatocellular carcinoma.
  • - Lung cancer.
  • - Medullary thyroid cancer.
  • - Neuroendocrine neoplasias.
  • - Ovarian cancer.
  • - Pancreatic cancer.
  • - Penile cancer.
  • - Peritoneal cancer.
  • - Pleural cancer.
  • - Prostate cancer.
  • - Sarcoma.
  • - Salivary gland cancer.
  • - Solitary fibrous tumor.
  • - Skin cancer.
  • - Testicular cancer.
  • - Thymus cancer.
  • - Thyroid cancer.
  • - Urothelial cancer.
  • - Uterus cancer.
  • - Vaginal cancer.
  • - Patients are ≥ 18 years old at the time of the radiotracer administration.
  • - Patient can provide written informed consent.
  • - Patient is able to remain still for duration of imaging procedure (up to one hour)

    Exclusion Criteria:

    - Patient is pregnant or nursing.
- Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high-quality data

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07118176
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeremie Calais
Principal Investigator Affiliation UCLA / Jonsson Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anal Carcinoma, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphatic System Neoplasm, Hepatocellular Carcinoma, Lung Carcinoma, Malignant Adrenal Gland Neoplasm, Malignant Brain Neoplasm, Malignant Neoplasm of Unknown Primary, Malignant Solid Neoplasm, Malignant Testicular Neoplasm, Malignant Uterine Neoplasm, Neuroendocrine Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Penile Carcinoma, Pleural Carcinomatosis, Primary Peritoneal Carcinoma, Prostate Carcinoma, Salivary Gland Carcinoma, Sarcoma, Skin Carcinoma, Solitary Fibrous Tumor, Thymus Carcinoma, Thyroid Gland Carcinoma, Thyroid Gland Medullary Carcinoma, Urothelial Carcinoma, Vaginal Carcinoma
Additional Details

PRIMARY OBJECTIVE:

  • I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).
SECONDARY OBJECTIVE:
  • I. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV) and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.

Arms & Interventions

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.

Interventions

Procedure: - Computed Tomography

Undergo PET/CT

Other: - Fludeoxyglucose F-18

Given IV

Radiation: - Gallium Ga 68 FAPi-46

Given IV

Procedure: - Positron Emission Tomography

Undergo PET/CT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles 5368361, California 5332921

Status

Recruiting

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90095

Site Contact

Jeremie Calais

[email protected]

310-825-3617

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