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

Jonsson Comprehensive Cancer Center

Status and phase: Enrolling; Phase 1

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

Treatments: Radiation: Gallium Ga 68 FAPi-46; Other: Fludeoxyglucose F-18; Procedure: Computed Tomography; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT07118176

NCI-2025-04961 (Registry Identifier)

25-0201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Positron Emission Tomography

Other: Fludeoxyglucose F-18

Procedure: Computed Tomography

Radiation: Gallium Ga 68 FAPi-46