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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

Summary

This trial tests a new scan to help see where cancer is in patients. The scan highlights cancer cells, which could help doctors find and understand cancer better.

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.
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.
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.

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.

Timeline

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 68Ga-FAPi-46 in normal and cancer tissues
Secondary study objectives
68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution
68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)
Other study objectives
Positron-Emission Tomography

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
2017
Completed Phase 4
~750
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy damages the DNA of cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. The investigational imaging agent 68Ga-FAPi-46 PET/CT targets fibroblast activation protein (FAP) in cancer-associated fibroblasts, which are cells that support tumor growth and progression. This imaging technique helps in identifying the extent and location of tumors, enabling more precise treatment planning. Understanding these mechanisms is crucial for cancer patients as it allows for personalized treatment strategies that can improve outcomes and reduce side effects.
Design and validation of fibroblast activation protein alpha targeted imaging and therapeutic agents.Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
35,144 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
~4 spots leftby Jul 2025