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

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

Positron Emission Tomography/computed tomography

FLT-PET/CT

About this trial

This is an interventional diagnostic trial for Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

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

Correlate SUV with % Ki67 nuclear stain

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01018251

First Posted

November 18, 2009

Last Updated

December 14, 2015

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01018251

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Withdrawn

Study Start Date

March 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Other Intervention Name(s)

18F-FLT

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography/computed tomography

Intervention Type

Radiation

Intervention Name(s)

FLT-PET/CT

Primary Outcome Measure Information:

Title

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

Title

Correlate SUV with % Ki67 nuclear stain

Secondary Outcome Measure Information:

Title

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

Title

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Learn more about this trial

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

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