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

NCT ID: NCT01018251

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Given IV

Positron Emission Tomography/computed tomography

Intervention Type PROCEDURE

FLT-PET/CT

Intervention Type RADIATION

Interventions

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

Given IV

Intervention Type OTHER

Positron Emission Tomography/computed tomography

Intervention Type PROCEDURE

FLT-PET/CT

Intervention Type RADIATION

Other Intervention Names

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18F-FLT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Abramson Cancer Center of the University of Pennsylvania

Countries

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United States

Other Identifiers

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UPCC 01109

Identifier Type: -

Identifier Source: org_study_id