68-Ga-FAPI PET Imaging in Malignancy

NCT ID: NCT04023240

Last Updated: 2024-08-12

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2023-12-14

Brief Summary

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This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.

Detailed Description

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PRIMARY OBJECTIVE:

To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.

OUTLINE:

Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.

After completion of study, patients are followed up at 24-72 hours.

Conditions

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Cancer

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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68Ga-FAPI PET/CT

Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.

Group Type EXPERIMENTAL

68Ga-FAPI

Intervention Type DRUG

68Ga-FAPI is quinoline based PET radiopharmaceutical.

68Ga-FAPI is administered intravenously (IV)

Computed Tomography (CT) scan

Intervention Type PROCEDURE

Participants will have a CT scan for attenuation correction and anatomic localization of PET data.

Positron Emission Tomography (PET) scan

Intervention Type PROCEDURE

PET images will be acquired.

Interventions

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68Ga-FAPI

68Ga-FAPI is quinoline based PET radiopharmaceutical.

68Ga-FAPI is administered intravenously (IV)

Intervention Type DRUG

Computed Tomography (CT) scan

Participants will have a CT scan for attenuation correction and anatomic localization of PET data.

Intervention Type PROCEDURE

Positron Emission Tomography (PET) scan

PET images will be acquired.

Intervention Type PROCEDURE

Other Intervention Names

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68-Ga-Fibroblast activation protein inhibitor (FAPI)

Eligibility Criteria

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Inclusion Criteria

* Patient with current malignancy confirmed via pathology or imaging
* Patient must be \> 18 years old
* Patient must be willing and able to provide written informed consent for the trial
* Patient of reproductive potential will have a pregnancy test

Exclusion Criteria

* Pregnant or breastfeeding
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carina A Mari, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

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Stanford University Hospitals and Clinics

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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VAR0195

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-52129

Identifier Type: -

Identifier Source: org_study_id

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