NCT05226663

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo \[18F\]FFT PET/CT
RADIATION	Fluorine F 18 Fluorthanatrace	Given IV
PROCEDURE	Positron Emission Tomography	Undergo \[18F\]FFT PET/CT

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-08-20
• Completion: 2026-08-20
• First posted: 2022-02-07
• Last updated: 2025-12-15

Locations

3 sites across 1 country: United States