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NCT Number: NCT05226663

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

This phase II trial tests whether [18F]FluorThanatrace by positron emission tomography (PET)/computed tomography (CT) can improve imaging techniques in patients with breast cancer undergoing a standard of care biopsy or surgery. [18F]FluorThanatrace is a new radioactive tracer, which is a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, [18F]FluorThanatrace. Because some cancers take up [18F]FluorThanatrace it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. [18F]FluorThanatrace by PET/CT may help detect the activity of a certain enzyme in the body that may be related to cancer growth in patients with breast cancer.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Siteman Cancer Center at Washington University, St Louis, Missouri, United States

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About this study

PRIMARY OBJECTIVE:

I. Correlate [18F]FluorThanatrace (FTT) PET/CT uptake in patients with primary breast cancer compared to PARP1 quantitative immunohistochemistry (IHC) as the tissue reference standard.

SECONDARY OBJECTIVES:

I. Correlate [18F]FluorThanatrace uptake with other measures of PARP-1 activity in tumor tissue samples - quantitative IHC, immunofluorescence (IF) and [125I]KX1 autoradiography.

II. Determine the ranges of uptake on [18F]FluorThanatrace PET/CT imaging across patients with breast cancer undergoing [18F]FTT PET/CT.

III. Demonstrate the reproducibility of [18F]FTT uptake on PET/CT using test-retest imaging.

IV. Confirm the safety of [18F]FluorThanatrace.

OUTLINE:

Patients receive [18F]FTT intravenously (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will be >= 18 years of age
  • Known primary breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard clinical imaging (e.g. mammogram, ultrasound, breast magnetic resonance imaging [MRI])
  • A candidate for primary breast surgery (mastectomy or lumpectomy)
  • Participants must be informed of the investigational nature of this study and provide written informed consent, in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion criteria

  • Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to injection of FTT
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Current or prior therapy for the primary breast cancer
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Treatment and study plan

Computed Tomography

Procedure

Undergo [18F]FFT PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Fluorine F 18 Fluorthanatrace

Radiation

Given IV

Other names: [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18

Positron Emission Tomography

Procedure

Undergo [18F]FFT PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

    The primary breast cancer tumor site is determined by standardized uptake values (SUV) based quantitative measures and PARP is measured by PARP1 mmunohistochemistry (IHC). This will be summarized as mean and standard deviation across patients.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Trevarx Biomedical, Inc

Registry information

Official study title

Imaging Using the Novel Radiotracer [18F] FluorThanaTrace([18F]FTT) by PET/CT in Patients With Breast Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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