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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Other: screening questionnaire administration
* Procedure: computed tomography
* Procedure: lymphoscintigraphy
* Procedure: single photon emission computed tomography
* Radiation: intensity-modulated radiation therapy
* Radiation: technetium Tc 99m sulfur colloid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: screening questionnaire administration|nan|
|Procedure: computed tomography|nan|
|Procedure: lymphoscintigraphy|nan|
|Procedure: single photon emission computed tomography|nan|
|Radiation: intensity-modulated radiation therapy|nan|
|Radiation: technetium Tc 99m sulfur colloid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, stage I breast cancer, stage II breast cancer