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
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.
Other: screening questionnaire administration
Procedure: computed tomography
Procedure: single photon emission computed tomography
Radiation: intensity-modulated radiation therapy
Radiation: technetium Tc 99m sulfur colloid
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing|
- Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration [ Designated as safety issue: No ]
- Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT® [ Designated as safety issue: No ]
- Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy [ Designated as safety issue: No ]
- Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||October 2016|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743314
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Andrea L. Cheville, MD, PhD||Mayo Clinic|