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FAPi PET/CT Imaging for Cancer (FAPI PET RDRC Trial)

Phase 1

Recruiting

Led By Jeremie Calais

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 or tissue biopsy 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 year 2

Awards & highlights

FAPI PET RDRC Trial Summary

This trial is looking at a new way to image cancer using a tracer called 68Ga-FAPi-46. The tracer is taken up by some cancers, and can be seen with PET imaging. This may provide additional information about various cancers in the future.

Who is the study for?

This trial is for adults with various cancers, including brain, bladder, testicular, skin, thyroid, liver cancer and more. Participants must be able to stay still for imaging procedures up to an hour and are scheduled for surgery or biopsy of the tumor. Pregnant or nursing individuals or those starting new cancer therapies before the study's PET/CT scans cannot join.Check my eligibility

What is being tested?

The study tests a new imaging technique using 68Ga-FAPi-46 PET/CT to see how well it shows where FAPI tracer accumulates in both normal and cancer tissues. This could help understand different cancers better by visualizing a protein associated with tumor-surrounding cells.See study design

What are the potential side effects?

As this is an imaging study involving PET/CT scans with tracers like Gallium Ga 68 FAPi-46 and not drug treatments, side effects may include discomfort from staying still during the scan and exposure to radiation typical of such diagnostic procedures.

FAPI PET RDRC Trial 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 or biopsy my cancer.

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I can stay still for up to an hour.

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I am 18 years old or older.

FAPI PET RDRC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues

Secondary outcome measures

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

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

Other outcome measures

Positron-Emission Tomography

FAPI PET RDRC Trial Design

1Treatment groups

Experimental Treatment

Group I: Basic science (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

18F-FDG

2010

Completed Phase 2

~660

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,682 Total Patients Enrolled

Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

7 Previous Clinical Trials

1,343 Total Patients Enrolled

Media Library

Gallium Ga 68 FAPi-46 Clinical Trial Eligibility Overview. Trial Name: NCT04459273 — Phase 1

Gallium Ga 68 FAPi-46 2023 Treatment Timeline for Medical Study. Trial Name: NCT04459273 — Phase 1

Cancer Research Study Groups: Basic science (68GA-FAPI-46 PET/CT)

Cancer Clinical Trial 2023: Gallium Ga 68 FAPi-46 Highlights & Side Effects. Trial Name: NCT04459273 — Phase 1

Frequently Asked Questions

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

What is the total number of participants in this clinical investigation?

"Correct - this medical experiment, which was initially advertised on August 27th 2020, is still actively looking for participants. A total of 30 patients are being recruited from a single location."

Answered by AI

Are there any unfilled positions in this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical study, which was made available on August 27th 2020, is currently accepting applicants. In total, 30 patients are required to be recruited from a single location."

Answered by AI