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

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

Official title:

Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01018251
• Other study ID #: UPCC 01109
• Status: Withdrawn
• Phase: N/A
• First received: November 18, 2009
• Last updated: December 14, 2015
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Other:
• 3'-deoxy-3'-[18F]fluorothymidine
Given IV

Procedure:
• Positron Emission Tomography/computed tomography

Radiation:
• FLT-PET/CT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of FLT-PET comparing with standard FDG-PET			No
Primary	Correlate SUV with % Ki67 nuclear stain			No
Secondary	Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)			No
Secondary	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)			No