NCT04457258

68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. 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: I. 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-). III. 3. To determine FAP expression profile and identify activating and loss of function mutations and gene rearrangement in available tumor tissue samples from patients with localized or metastatic sarcoma using RNA sequencing OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Conditions

• Metastatic Sarcoma
• Recurrent Sarcoma
• Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Gallium Ga 68 FAPi-46	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
RADIATION	18F-FDG	Given IV

Timeline

• Start date: 2020-09-08
• Primary completion: 2026-07-01
• Completion: 2027-07-21
• First posted: 2020-07-07
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study