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Sponsored by: |
Royal Marsden - Surrey |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602628 |
RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer.
PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.
Condition | Intervention |
---|---|
Breast Cancer |
Procedure: adjuvant therapy Procedure: biopsy Procedure: computed tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance imaging Procedure: questionnaire administration Procedure: radiation therapy Procedure: therapeutic conventional surgery Procedure: ultrasound imaging |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY? |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium clips to the four radial, the deep, and superficial margins of the excision cavity (for localization of tumor bed).
Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone position. Patients complete a linear analogue questionnaire after both scans designed to assess patient comfort and anxiety in each position. Patients then undergo multifunctional MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥ 5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients undergo MRI-guided biopsy. Lesions < 5 mm are included in the whole-breast radiotherapy treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Royal Marsden - Surrey | |
Sutton, England, United Kingdom, SM2 5PT |
Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000581130, RMH-CCR2981 |
Study First Received: | January 24, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00602628 |
Health Authority: | United States: Federal Government |
ductal breast carcinoma in situ invasive ductal breast carcinoma breast cancer in situ |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary |