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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00109785 |
RATIONALE: Imaging procedures such as PET scans may improve the ability to monitor the effectiveness of chemotherapy for locally advanced breast cancer.
PURPOSE: This clinical trial is studying how well PET scans work in patients with locally advanced breast cancer who will undergo chemotherapy.
Condition | Intervention |
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Breast Cancer |
Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: iodine I 124 iododeoxyuridine |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Positron Emitter I-124-Iododeoxyuridine to Follow DNA Metabolism on Scans and in Tumor Samples in Advanced Breast Cancer: Comparison to 18-F-2-Fluoro-2-Deoxy-(D)-Glucose, as a Tracer for Glycolysis |
Estimated Enrollment: | 20 |
Study Start Date: | March 1997 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: For this study, the chemotherapy administered for an individual patient is at the discretion of the patient's primary attending physician. After chemotherapy, the patient is evaluated for surgical resection of the tumor. If the tumor is unresectable, the patient may be offered radiation therapy.
The first group of positron emission tomography (PET) scans is performed within 2 weeks before the first dose of chemotherapy. The second group of PET scans occur no more than 7 weeks after chemotherapy and prior to local therapy, either surgery or radiation therapy.
The PET scan before initiation of chemotherapy consists of 4 imaging sessions. There is one iodine I-124 iododeoxyuridine (IUdR) PET scan (3 imaging sessions) at 1, 4-8, and 24 hours after IUdR infusion, followed by one fludeoxyglucose (FDG) PET scan (1 imaging session) 45 minutes after FDG infusion.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced breast carcinoma
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Study Chair: | Teresa Ann Gilewski, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000065706, MSKCC-97046, NCI-G97-1308 |
Study First Received: | May 3, 2005 |
Last Updated: | July 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00109785 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
Anti-Infective Agents Skin Diseases Breast Neoplasms, Male Iodine Breast Neoplasms |
Breast Cancer, Male Antiviral Agents Idoxuridine Breast Diseases |
Anti-Infective Agents Skin Diseases Molecular Mechanisms of Pharmacological Action Breast Neoplasms Enzyme Inhibitors Idoxuridine Antiviral Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases Nucleic Acid Synthesis Inhibitors |