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

Clinicaltrials.gov ID: NCT07118176
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

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

Summary

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.

Detailed Description

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Jeremie Calais

Eligibility 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

Study Plan

Diagnostic (68Ga-FAPi-46 PET/CT)

EXPERIMENTAL

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.

  • PROCEDURE:

    Computed Tomography

    Description:

    Undergo PET/CT

  • OTHER:

    Fludeoxyglucose F-18

    Description:

    Given IV

  • RADIATION:

    Gallium Ga 68 FAPi-46

    Description:

    Given IV

  • PROCEDURE:

    Positron Emission Tomography

    Description:

    Undergo PET/CT

Outcome Measures

Primary Outcome Measures

Biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46)

Time Frame: Up to 2 years

Secondary Outcome Measures

Fludeoxyglucose F-18 (18F-FDG) biodistribution

Time Frame: Up to 2 years

Timeline

  • Last Updated
    August 12, 2025
  • Start Date
    August 12, 2025
  • Today
    November 9, 2025
  • Completion Date ( Estimated )
    September 7, 2027

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