Breast Cancer Clinical Trial
Official title:
Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing
Verified date | October 2018 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration | |||
Primary | Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT® | |||
Primary | Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy | |||
Primary | Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements |
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