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

This study has been completed.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01018251
First received: November 18, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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,


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Sensitivity and specificity of FLT-PET comparing with standard FDG-PET [ Designated as safety issue: No ]
  • Correlate SUV with % Ki67 nuclear stain [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used) [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
Other: 3'-deoxy-3'-[18F]fluorothymidine
Given IV
Other Name: 18F-FLT
Procedure: Positron Emission Tomography/computed tomography Radiation: FLT-PET/CT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018251

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Julia Tchou, MD, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01018251     History of Changes
Other Study ID Numbers: UPCC 01109
Study First Received: November 18, 2009
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014