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

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Conditions:		Recurrent Breast Cancer - Stage II Breast Cancer - Stage IIIA Breast Cancer - Stage IIIB Breast Cancer - Stage IIIC Breast Cancer
Purpose:		This phase II trial is studying how well 3'-deoxy-3'-18F fluorothymidine PET/CT scanning works in patients undergoing treatment for stage III breast cancer. Diagnostic procedures, such as 3'-deoxy-3'-(18F) fluorothymidine positron emission tomography (PET)/CT scanning, may help in learning how well chemotherapy works to kill breast cancer cells and help doctors plan the best treatment.
Study Summary:		PRIMARY OBJECTIVES: I. To evaluate the relationship between 3'-deoxy-3'-18F fluorothymidine ([18F]FLT) uptake parameters and pathologic complete response to chemotherapy of the primary tumor in patients with locally advanced breast cancer. SECONDARY OBJECTIVES: I. To evaluate the relationship between [18F]FLT uptake parameters and the clinical anatomical (CT) and metabolic (fludeoxyglucose [FDG] PET uptake) response. II. To compare the utility of [18F]FLT and [18F]FDG uptake parameters for predicting early treatment response (response assessment prior to completion of therapy) in patients with locally advanced breast cancer. III. To demonstrate correlation between [18F]FLT uptake parameters and tumor proliferation markers in breast cancer. IV. To continue to monitor for potential safety issues and define any physiologic effects associated with [18F]FLT administration. OUTLINE: This is a multicenter study. On day 1, patients undergo 3'-deoxy-3'-(18F) fluorothymidine ( [18F]FLT) injection and immediately dynamic regional positron emission tomography (PET)/CT imaging for 60 minutes, followed by a static whole body image over approximately 30 minutes. A second static whole body image is taken at 120 minutes post [18F]FLT injection. On day 2, patients undergo[18F]FDG injection and PET/CT imaging 1 hour after injection. An additional regional PET/CT image including the primary tumor in the field of view is performed beginning at 2 hours after the injection of [18F]FDG. Patients undergo three 2-day imaging sessions at baseline before neoadjuvant chemotherapy, mid-neoadjuvant chemotherapy, and post-neoadjuvant chemotherapy before surgery. At the beginning and end of each imaging session, patients complete a questionnaire indicating any appearance or change in signs and symptoms. After completion of neoadjuvant chemotherapy, patients undergo surgical resection of residual tumor as planned.
Criteria:		Inclusion Criteria: - Pathologically confirmed breast cancer - Female patients must meet 1 of the following criteria: - Postmenopausal for a minimum of one year - Surgically sterile - not pregnant, confirmed by β-HCG blood test and willing to use adequate contraception during study participation - Tumor size > 2 cm measured by imaging or estimated by physical exam - Candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy - WBC >= 3,000/microL - Total bilirubin normal - AST/ALT =< 2.5 x upper limit of normal - Creatinine normal or creatinine clearance >= 60 mL/min - Able to lie still for 1.5 hours - No obvious contraindications for primary chemotherapy with docetaxel, doxorubicin hydrochloride, or cyclophosphamide - Platelet count >= 100,000/microL - No previous treatment (e.g., chemotherapy, radiotherapy, or surgery) that involved the breast - Absolute neutrophil count >= 1,500/microL Exclusion Criteria: - Not nursing - Must be medically stable - No uncontrolled intercurrent illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements - No condition requiring anesthesia for positron emission tomography (PET) scanning - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3'-deoxy-3'-18F fluorothymidine
NCT ID:		NCT00572728
Primary Contact:		Principal Investigator Lale Kostakoglu American College of Radiology Imaging Network
Backup Contact:		N/A
Location Contact:		Philadelphia, Pennsylvania 19103 United States There is no listed contact information for this specific location. Site Status: N/A

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