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Imaging Agent

FAPi PET/CT Imaging for Prostate Cancer (FAPI PET Prost Trial)

Phase 1
Waitlist Available
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 excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to date of surgery (range 1-60 days)
Awards & highlights

FAPI PET Prost Trial Summary

This trial is testing a new imaging technique to see if it can detect prostate cancer. The technique uses a tracer called 68Ga-FAPi-46 which is taken up by some cancer cells. If successful, this technique could provide additional information about various types of cancer in the future.

Who is the study for?
This trial is for men with prostate cancer who've had a PSMA PET/CT scan within the last 3 months and are scheduled for surgery or biopsy of their cancer. They must be able to give consent and stay still for up to an hour during imaging.Check my eligibility
What is being tested?
The study tests a new imaging method called FAPI PET/CT, which uses a tracer (68Ga-FAPi-46) to see how well it highlights prostate cancer in the body by targeting FAP, a protein often found near tumors.See study design
What are the potential side effects?
Since this is an imaging study using Gallium Ga 68 FAPi-46, side effects may include discomfort at injection site or allergic reactions but generally, PET/CT scans have minimal side effects.

FAPI PET Prost Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery or a biopsy for prostate cancer.

FAPI PET Prost Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to date of surgery (range 1-60 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to date of surgery (range 1-60 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
Secondary outcome measures
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
Malignant Neoplasms

FAPI PET Prost Trial Design

1Treatment groups
Experimental Treatment
Group I: Basic Science (68Ga-FAPi-46 PET/CT)Experimental Treatment3 Interventions
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,020 Total Patients Enrolled
38 Trials studying Prostate Cancer
3,970 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,750 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,900 Patients Enrolled for Prostate Cancer
Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
7 Previous Clinical Trials
1,343 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,057 Patients Enrolled for Prostate Cancer

Media Library

Gallium Ga 68 FAPi-46 (Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04457232 — Phase 1
Prostate Cancer Research Study Groups: Basic Science (68Ga-FAPi-46 PET/CT)
Prostate Cancer Clinical Trial 2023: Gallium Ga 68 FAPi-46 Highlights & Side Effects. Trial Name: NCT04457232 — Phase 1
Gallium Ga 68 FAPi-46 (Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457232 — Phase 1

Frequently Asked Questions

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

Are researchers currently seeking out participants for this clinical experiment?

"Clinicaltrials.gov has verified that this research is recruiting participants, with the posting date of September 9th 2020 and an update on September 23rd 2022."

Answered by AI

How many participants are presently joining the trial?

"Yes, clinicaltrials.gov affirms that this experiment is actively recruiting participants. The trial was initially made available on September 9th 2020 and has been edited most recently on the 23rd of September 2022. 30 individuals are required to be enrolled across 1 medical institution."

Answered by AI

Has the FDA sanctioned Gallium Ga 68 FAPi-46 for medical use?

"There is only minimal data on Ga 68 FAPi-46's safety and efficacy, so it recieved a score of 1."

Answered by AI
~2 spots leftby Sep 2024