Clinical Trials Directory

Trials / Completed

CompletedNCT00572728

Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

3'-Deoxy-3'-18F Fluorothymidine PET/CT in Predicting Response To Chemotherapy Before Surgery in Patients With Locally Advanced Breast Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
90 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. To correlate the percentage change in standardized uptake value at 60 minutes (SUV60) between baseline (FLT-1) and early-therapy (FLT-2) with pathologic complete response to neoadjuvant chemotherapy of the primary tumor in patients with locally advanced breast cancer. SECONDARY OBJECTIVES: I. To demonstrate correlation between FLT-1 and post-therapy (FLT-3) uptake parameters and tumor proliferation markers in locally advanced breast cancer. II. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response of the primary tumor and residual cancer burden (RCB). III. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and non-response of the primary tumor (stable or progressive disease) to therapy. IV. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response to neoadjuvant chemotherapy in patients with regional disease in the lymph nodes in patients with locally advanced breast cancer. V. To compare the changes of FLT-2 and FLT-3 uptake parameters to changes in tumor sizes from other serial imaging modalities such as mammograms, magnetic resonance imaging (MRI), and ultrasound. VI. To compare the changes of FLT-2 and FLT-3 uptake parameters to metabolic changes from \[18F\] fludeoxyglucose (FDG)-PET, as available. VII. To continue to monitor for potential safety issues and define any physiologic effects associated with 18F FLT administration. OUTLINE: Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Conditions

Interventions

TypeNameDescription
PROCEDURECTUndergo 18F-FLT PET/CT
DRUG18F-FLTUndergo 18F-FLT PET/CT
PROCEDUREPETUndergo 18F-FLT PET/CT

Timeline

Start date
2008-12-01
Primary completion
2014-09-01
Completion
2014-10-01
First posted
2007-12-13
Last updated
2016-12-30
Results posted
2016-01-20

Locations

27 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00572728. Inclusion in this directory is not an endorsement.