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68Ga-FAPi-46 PET/CT Imaging for Sarcoma

Phase < 1

Recruiting

Led By Jeremie Calais, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are able to remain still for duration of imaging procedures (up to one hour for each)

Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an imaging technique that uses a small amount of radioactivity and a tracer called 68Ga-FAPi-46 to see where and how much the tracer accumulates in normal and cancerous tissues in patients with sarcoma.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed sarcoma who can consent and stay still for imaging. It's not for pregnant/nursing individuals or those with conditions that could affect data quality.

What is being tested?

The trial tests a new imaging technique, 68Ga-FAPi-46 PET/CT, to see how well it shows sarcoma in the body compared to standard methods by tracking a tracer absorbed by cancer cells.

What are the potential side effects?

Potential side effects may include reactions to the tracer like mild pain or discomfort at injection site. The CT scan involves exposure to low levels of radiation similar to standard medical imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stay still for up to an hour during scans.

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I am scheduled for surgery to remove or biopsy a suspected sarcoma.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (68Ga-FAPI-46 PET/CT)Experimental Treatment4 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

18F-FDG

2017

Completed Phase 4

~750