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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)

Must not have

Females who are pregnant or breast feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790

Positron Emission Tomography

2011

Completed Phase 2

~2200