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68-Ga-FAPI PET Imaging in Malignancy

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Stanford University

Status and phase

Withdrawn
Phase 2

Conditions

Cancer

Treatments

Drug: 68Ga-FAPI
Procedure: Computed Tomography (CT) scan
Procedure: Positron Emission Tomography (PET) scan

Study type

Interventional

Funder types

Other

Identifiers

NCT04023240
IRB-52129
VAR0195 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

19 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

68Ga-FAPI PET/CT
Experimental group
Description:
Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.
Treatment:
Procedure: Positron Emission Tomography (PET) scan
Procedure: Computed Tomography (CT) scan
Drug: 68Ga-FAPI

Trial contacts and locations

1

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Central trial contact

Risa Jiron

Data sourced from clinicaltrials.gov

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