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

NCT05226663 | Active Not Recruiting Phase 2

• 3 other identifiers: 2021-0768NCI-2021-12680R01CA258717
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  through study completion, an average of 1 year

Study Arms (1)

Treatment ([18F]FTT PET/CT)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Radiation: Fluorine F 18 Fluorthanatrace; Procedure: Positron Emission Tomography

Interventions

Fluorine F 18 Fluorthanatrace RADIATION

Given IV

Also known as: [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18

Treatment ([18F]FTT PET/CT)

Computed Tomography PROCEDURE

Undergo \[18F\]FFT PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment ([18F]FTT PET/CT)

Positron Emission Tomography PROCEDURE

Undergo \[18F\]FFT PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment ([18F]FTT PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Trevarx Biomedical, Inc: collaborator

Study Sites (3)

Siteman Cancer Center at Washington University

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lilie L Lilie

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: February 27, 2023
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (3)