NCT00743314

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer
• Lymphedema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2008-08-28
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States