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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-09-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Gallium Ga 68 FAPi-46

Intervention Type RADIATION

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Given IV

Intervention Type OTHER

Gallium Ga 68 FAPi-46

Given IV

Intervention Type RADIATION

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography 18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 (68GA)Ga-FAPI-46 68Ga-FAPi-46 FAPI-46 GA-68 Gallium-68-FAPI-46 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No