68-Ga-FAPI PET Imaging in Malignancy

Phase 2

Withdrawn

• Conditions: Cancer
• Interventions: Drug: 68Ga-FAPI; Procedure: Computed Tomography (CT) scan; Procedure: Positron Emission Tomography (PET) scan

• Registration Number: NCT04023240
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Study Start: 2023-07
• Primary Completion: 2023-07-14
• Study Completion: 2023-12-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Pregnant or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI PET/CT	Computed Tomography (CT) scan	Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
68Ga-FAPI PET/CT	68Ga-FAPI	Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
68Ga-FAPI PET/CT	Positron Emission Tomography (PET) scan	Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.

Primary Outcome Measures

Name	Time	Method
Feasibility of 68Ga-FAPI PET	24 months	Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if \> 50% of scans will have a score of 3 or more

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States