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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018251

Enrollment

Registered

2009-11-23

Start date

2009-03-31

Completion date

2011-06-30

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHER3'-deoxy-3'-[18F]fluorothymidine

Given IV

PROCEDUREPositron Emission Tomography/computed tomography

RADIATIONFLT-PET/CT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET	—
Correlate SUV with % Ki67 nuclear stain	—

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026