Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

Study Purpose

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

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 cancer types: - Brain cancer.
  • - Bladder cancer.
  • - Urothelial cancer.
  • - Testicular cancer.
  • - Skin cancer.
  • - Thyroid cancer.
  • - Hepatocellular carcinoma.
  • - Cholangiocarcinoma.
  • - Thymus cancer.
  • - Pleural cancer.
  • - Cervical cancer.
  • - Adrenal cancer.
  • - Neuroendocrine tumors.
  • - Hematologic cancer.
  • - Cancer of Unkown Primary.
  • - Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis.
  • - 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.
  • - Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT.
- 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.

NCT04459273
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.

Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm, Malignant Brain Neoplasm, Malignant Pleural Neoplasm, Malignant Skin Neoplasm, Malignant Solid Neoplasm, Malignant Testicular Neoplasm, Malignant Thymus Neoplasm, Neuroendocrine Neoplasm, Thyroid Gland Carcinoma, Urothelial Carcinoma, Cancer of Unknown Primary Site
Additional Details

PRIMARY OBJECTIVE:

  • I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.
SECONDARY OBJECTIVES:
  • I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.
  • II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) EXPERIMENTAL OBJECTIVE: To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available.
OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Arms & Interventions

Arms

Experimental: Basic science (68GA-FAPI-46 PET/CT)

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Interventions

Procedure: - Computed Tomography

Undergo PET/CT

Drug: - Gallium Ga 68 FAPi-46

Given IV

Procedure: - Positron Emission Tomography

Undergo PET/CT

Radiation: - 18F-FDG

Given IV

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, California

Status

Recruiting

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Site Contact

Ethan Lam

[email protected]

310-206-7372

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