Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)

Description

Summary

This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with sarcoma. 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. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.

Official Title

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation

Details

PRIMARY OBJECTIVE:

  1. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with histopathology validation.

SECONDARY OBJECTIVES:

  1. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) reflects geography, extent and degree of FAP expression determined by immuno-histochemistry (IHC).

II. 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 positive [+]/ FDG+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes.

Keywords

Metastatic Sarcoma Recurrent Sarcoma Sarcoma Computed Tomography Gallium Ga 68 FAPi-46 Positron Emission Tomography

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients who underwent a 18F-FDG PET/CT scan within 3 months of enrollment.
  • Patients who are scheduled to undergo surgical excision or biopsy of a sarcoma primary, recurrent or metastatic lesion.
  • Patients who can provide written informed consent.
  • Patients who are able to remain still for duration of imaging procedure (up to one hour).

You CAN'T join if...

  • Patients with any new sarcoma therapy between the 18F-FDG PET/CT and the FAPI PET/CT.

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04457258
Phase
Phase 1
Study Type
Interventional
Last Updated