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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

Study 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.Check my eligibility
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.See study design
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.
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I have one of the listed types of cancer.
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I can follow the study's required procedures.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Malignant Neoplasms
Secondary outcome measures
68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation
evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
Other outcome measures
Additional correlation of biodistribution of standard of care tracer

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
Computed Tomography
2017
Completed Phase 2
~2790
Gallium Ga 68-labeled PSMA-11
2019
Completed Phase 2
~1030
18F-FDG
2010
Completed Phase 2
~660
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,046 Total Patients Enrolled
Society of Nuclear Medecine and Molecular ImagingUNKNOWN
Jeremie Calais, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
5 Previous Clinical Trials
152 Total Patients Enrolled

Media Library

Gallium Ga 68-labeled PSMA-11 Clinical Trial Eligibility Overview. Trial Name: NCT04147494 — Phase < 1
Tumors Research Study Groups: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)
Tumors Clinical Trial 2023: Gallium Ga 68-labeled PSMA-11 Highlights & Side Effects. Trial Name: NCT04147494 — Phase < 1
Gallium Ga 68-labeled PSMA-11 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147494 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for prospective participants in this medical experiment?

"According to clinicaltrials.gov, this study is actively enrolling participants into its research cohort. The trial was initially posted on November 5th 2019 and underwent its most recent revision on the 29th of November 2022."

Answered by AI

How many participants can be included in this research project?

"Indeed, according to clinicaltrials.gov, this medical study is actively enrolling participants at the moment. It was first published on November 5th 2019 and recently updated on November 29th 2022 with a maximum enrolment of 30 patients across 1 site."

Answered by AI
~18 spots leftby Jun 2030