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Fluorine F 18 Fluorthanatrace PET/CT Imaging for Breast Cancer

Phase 2

Recruiting

Led By Lilie L Lilie

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be >= 18 years of age

A candidate for primary breast surgery (mastectomy or lumpectomy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing a new imaging agent, [18F]FluorThanatrace, to see if it can improve imaging techniques in patients with breast cancer.

Who is the study for?

This trial is for adults over 18 with breast cancer who are candidates for primary breast surgery and have a tumor of at least 1.0 cm visible on imaging. It's not for those pregnant, breastfeeding, previously treated for their breast cancer, unable to tolerate imaging procedures, or with conditions that may compromise safety or participation.Check my eligibility

What is being tested?

[18F]FluorThanatrace by PET/CT is being tested to see if it can improve imaging in patients undergoing biopsy or surgery for breast cancer. This new radioactive tracer might help detect enzyme activity related to cancer growth when used with PET/CT scans.See study design

What are the potential side effects?

Potential side effects from the radioactive tracer [18F]FluorThanatrace could include reactions at the injection site, allergic reactions to the compound, and exposure to radiation which carries a risk of causing future cancers.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am a candidate for surgery to remove breast cancer.

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My breast cancer has a tumor that is at least 1.0 cm big, confirmed by imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Correlation of [18F]FluorThanatrace (FTT) uptake with PARP expression

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ([18F]FTT PET/CT)Experimental Treatment3 Interventions

Patients receive [18F]FTT IV over a few seconds to a minute and then undergo PET/CT scan over 20-30 minutes at baseline and another optional scan 1 week later. During the [18F]FTT PET/CT scan patients.

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,285 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,969 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Trevarx Biomedical, IncUNKNOWN

Media Library

Fluorine F 18 Fluorthanatrace Clinical Trial Eligibility Overview. Trial Name: NCT05226663 — Phase 2

Breast Cancer Research Study Groups: Treatment ([18F]FTT PET/CT)

Breast Cancer Clinical Trial 2023: Fluorine F 18 Fluorthanatrace Highlights & Side Effects. Trial Name: NCT05226663 — Phase 2

Fluorine F 18 Fluorthanatrace 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226663 — Phase 2

Frequently Asked Questions

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

Is there still an opportunity to register for this trial?

"Indeed, according to clinicaltrials.gov, this medical experiment - which was initiated on April 1st 2022 - is currently in the process of recruiting participants. A total of 36 patients must be enrolled at a single site."

Answered by AI

Are there adverse effects associated with Fluorine F 18 Fluorthanatrace for patients?

"Our team assessed the safety of Fluorine F 18 Fluorthanatrace to be a 2, since this is Phase 2 and there have been some studies demonstrating its security but not any proving its efficacy."

Answered by AI

How many participants are being observed for this clinical experiment?

"Affirmative. As per the information stored on clinicaltrials.gov, this medical investigation is currently inviting candidates to participate; it was initially posted on April 1st 2022 and most recently updated on September 7th 2022. 36 individuals are being solicited from a single centre for inclusion in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer

2023. "A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226663.