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

Not Applicable

Withdrawn

• Conditions: Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)
• Interventions: Other: 3'-deoxy-3'-[18F]fluorothymidine; Procedure: Positron Emission Tomography/computed tomography; Radiation: FLT-PET/CT

• Registration Number: NCT01018251
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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,

Detailed Description

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	3'-deoxy-3'-[18F]fluorothymidine	Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy
Arm I	Positron Emission Tomography/computed tomography	Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy
Arm I	FLT-PET/CT	Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
Correlate SUV with % Ki67 nuclear stain
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET

Secondary Outcome Measures

Name	Time	Method
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)