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
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|ClinicalTrials.gov Identifier: NCT00743314|
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Lymphedema||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|
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing|
|Study Start Date :||September 2008|
|Primary Completion Date :||October 2016|
|Study Completion Date :||October 2016|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743314
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Andrea L. Cheville, MD, PhD||Mayo Clinic|