NCT04457258

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
15mo left

Started Sep 2020

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2020Jul 2027

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2027

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

5.8 years

First QC Date

June 30, 2020

Last Update Submit

August 7, 2025

Conditions

Metastatic SarcomaRecurrent SarcomaSarcoma

Outcome Measures

Primary Outcomes (1)

  • Biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues

    Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

    At 20-90 minutes after injection

Secondary Outcomes (2)

  • 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)

    Up to year 2

  • Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

    Up to year 2

Study Arms (1)

Diagnostic (68Ga-FAPI-46 PET/CT)

EXPERIMENTAL

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).

Procedure: Computed TomographyDrug: Gallium Ga 68 FAPi-46Procedure: Positron Emission TomographyRadiation: 18F-FDG

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Diagnostic (68Ga-FAPI-46 PET/CT)
Gallium Ga 68 FAPi-46DRUG

Given IV

Also known as: 68Ga-FAPi-46, Gallium-68-FAPi-46
Diagnostic (68Ga-FAPI-46 PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (68Ga-FAPI-46 PET/CT)
18F-FDGRADIATION

Given IV

Also known as: 18F-fluorodeoxyglucose
Diagnostic (68Ga-FAPI-46 PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion.
  • Patients who are ≥ 18 years old at the time of the radiotracer administration.
  • Patients who can provide written informed consent.
  • Patients who are able to remain still for duration of imaging procedures (up to one hour for each).

You may not qualify if:

  • Patient is pregnant or nursing.
  • Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
  • Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

FAPI-46Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Jeremie Calais, MD

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

September 8, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 21, 2027

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

US(1)