Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Lymphedema
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief 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 pr...
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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00743314
Start Date
September 1 2008
End Date
October 1 2016
Last Update
October 9 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905