Expired Study
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Rochester, Minnesota 55905


Purpose:

RATIONALE: Diagnostic procedures, such as single-photon emission computed tomography and computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after surgery, and help prevent lymphedema. PURPOSE: This clinical trial is studying single-photon emission computed tomography and computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to see how well they work in treating patients who have undergone surgery for stage I or stage II breast cancer.


Study summary:

OBJECTIVES: - To assess the feasibility of integrating Philips Precedence SPECT/CT® images with GE PET/CT Fusion software to reduce radiation dosimetry delivered to lymph nodes draining the arm in patients after surgery for stage I or II breast cancer. - To examine the differences in radiation dosimetry in these patients using 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®. - To compare reduction in lymph node radiation dosimetry in these patients using single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy. OUTLINE: Patients receive filtered technetium Tc 99m sulfur colloid (TcSC) intradermally and undergo single photon emission computed tomography (SPECT) and computed tomography (CT) imaging at the time of TcSC and 2 hours after injection. Patients then undergo intensity-modulated radiotherapy of the whole breast, including the low axilla and lymph nodes identified by the Phillips Precedence SPECT/CT® at a dose determined by computer analysis of the imaging information. Patients complete a lymphedema screening questionnaire at baseline and at 12 and 24 months after treatment.


Criteria:

DISEASE CHARACTERISTICS: - Biopsy-proven primary invasive breast cancer, meeting one of the following criteria: - Stage I or II disease with negative sentinel or axillary node dissections - Stage II disease with micrometastases (defined as < 2.0 mm focus) in 1-2 lymph nodes and/or a single positive axillary node ≤ 1 cm with no extracapsular extension - Completed all surgical intervention (e.g., lumpectomy, mastectomy) - Planning adjuvant whole breast irradiation including the low axilla - No bilateral or recurrent breast cancer PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Not pregnancy or nursing - Negative pregnancy test - Able to complete questionnaire(s) alone or with assistance - No active infection - No history of invasive cancer within the past 5 years, except basal cell or squamous cell skin cancers PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior surgery or radiation to the ipsilateral breast or axilla - No concurrent neoadjuvant chemotherapy or radiotherapy


NCT ID:

NCT00743314


Primary Contact:

Study Chair
Andrea L. Cheville, MD, PhD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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