Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

Abramson Cancer Center at Penn Medicine

Overview

This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)

Interventions

3'-deoxy-3'-[18F]fluorothymidineOTHER

Given IV

Positron Emission Tomography/computed tomographyPROCEDURE

FLT-PET/CTRADIATION

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy) * Participants must be planning to have surgery at the Hospital of the University of Pennsylvania * Participants must be able to tolerating lying on the table for about an hour * Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4) Exclusion Criteria: * Pregnant women * History of severe renal disease * Prior history of breast cancer of the study breast within the last five years.

Outcomes

Primary Outcomes

Sensitivity and specificity of FLT-PET comparing with standard FDG-PET

Correlate SUV with % Ki67 nuclear stain

Secondary Outcomes

Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)

Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)

Data from ClinicalTrials.gov

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