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

November 18, 2009
October 11, 2012
March 2009
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01018251 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer
Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)
  • Other: 3'-deoxy-3'-[18F]fluorothymidine
    Given IV
    Other Name: 18F-FLT
  • Procedure: Positron Emission Tomography/computed tomography
  • Radiation: FLT-PET/CT
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
Interventions:
  • Other: 3'-deoxy-3'-[18F]fluorothymidine
  • Procedure: Positron Emission Tomography/computed tomography
  • Radiation: FLT-PET/CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018251
UPCC 01109
Yes
Julia Tchou, MD, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP