Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer

Early Phase 1CompletedNCT00743314

Mayo Clinic30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration

Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®

Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy

Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements