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FAPi & PSMA PET/CT Imaging for Cancer Detection

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 scheduled to undergo surgical resection of the primary tumor and/or metastasis

Patient is able to remain still for duration of imaging procedure (up to one hour)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is using a new imaging technique, FAPi PET/CT, to study how well it can detect cancer in patients with non-prostate cancer. The team is also interested in using another new imaging technique, PSMA PET/CT. Patients will have PET/CT scans with either the FAPI or PSMA tracer. This trial is to see if these new techniques are effective in detecting cancer.

Who is the study for?

This trial is for patients scheduled for cancer surgery who can consent and comply with study procedures. It's open to those with breast, colon, esophageal, gastric, head and neck, lung, ovarian, pancreatic, renal or uterus cancer. Pregnant/nursing individuals or those whose conditions might affect data quality are excluded.

What is being tested?

The trial studies new PET/CT imaging techniques using tracers like Gallium Ga 68-labeled PSMA-11 and FAPi-46 to see how they accumulate in normal vs. cancer tissues. The goal is to match PET images with actual tumor tissue removed during surgery.

What are the potential side effects?

As this is an imaging study involving PET/CT scans with radioactive tracers (not a drug intervention), the main risks include exposure to radiation which is kept as low as possible.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for surgery to remove my cancer.

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I can stay still for up to an hour for a scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Malignant Neoplasms

Secondary study objectives

68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation

evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

Other study objectives

Additional correlation of biodistribution of standard of care tracer

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: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)Experimental Treatment5 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). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gallium Ga 68-labeled PSMA-11

2019

Completed Phase 2

~1030

Computed Tomography

2017

Completed Phase 2

~2790