← Back to Search

68Ga-FAPi-46 PET/CT Imaging for Sarcoma

Q: What is the current enrollment size of this experiment?

<p>Affirmative. The trial's launch was on September 8th 2020, as documented on clinicaltrials.gov, which also confirms that the study is actively seeking participants. Thirty individuals are sought to take part in this project at a single medical centre</p>

Q: Are there any vacancies left for participants in this trial?

<p>As evidenced by clinicaltrials.gov, this trial is currently enrolling patients which was initially posted on September 8th 2020 and has been recently updated on September 23rd 2022.</p>

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 able to remain still for duration of imaging procedures (up to one hour for each)

Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 2

Awards & highlights

Study Summary

This trial is testing an imaging technique that uses a small amount of radioactivity and a tracer called 68Ga-FAPi-46 to see where and how much the tracer accumulates in normal and cancerous tissues in patients with sarcoma.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed sarcoma who can consent and stay still for imaging. It's not for pregnant/nursing individuals or those with conditions that could affect data quality.Check my eligibility

What is being tested?

The trial tests a new imaging technique, 68Ga-FAPi-46 PET/CT, to see how well it shows sarcoma in the body compared to standard methods by tracking a tracer absorbed by cancer cells.See study design

What are the potential side effects?

Potential side effects may include reactions to the tracer like mild pain or discomfort at injection site. The CT scan involves exposure to low levels of radiation similar to standard medical imaging.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can stay still for up to an hour during scans.

Select...

I am scheduled for surgery to remove or biopsy a suspected sarcoma.

Select...

I am 18 years old or older.

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 Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues

Secondary outcome measures

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

Frequency of the following phenotypes (FAP positive [+]/ fludeoxyglucose [FDG]+, FAP negative [-]/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (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

Positron Emission Tomography

2008

Completed Phase 2

~2240

18F-FDG

2010

Completed Phase 2

~660

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

7 Trials studying Sarcoma

209 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,824 Total Patients Enrolled

454 Trials studying Sarcoma

230,175 Patients Enrolled for Sarcoma

Jeremie Calais, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

5 Previous Clinical Trials

152 Total Patients Enrolled

Media Library

Gallium Ga 68 FAPi-46 Clinical Trial Eligibility Overview. Trial Name: NCT04457258 — Phase < 1

Sarcoma Research Study Groups: Diagnostic (68Ga-FAPI-46 PET/CT)

Sarcoma Clinical Trial 2023: Gallium Ga 68 FAPi-46 Highlights & Side Effects. Trial Name: NCT04457258 — Phase < 1

Gallium Ga 68 FAPi-46 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457258 — 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 current enrollment size of this experiment?

"Affirmative. The trial's launch was on September 8th 2020, as documented on clinicaltrials.gov, which also confirms that the study is actively seeking participants. Thirty individuals are sought to take part in this project at a single medical centre"

Answered by AI

Are there any vacancies left for participants in this trial?

"As evidenced by clinicaltrials.gov, this trial is currently enrolling patients which was initially posted on September 8th 2020 and has been recently updated on September 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma

2020. "68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04457258.

All > Sarcoma