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
NCT ID: NCT00743314
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2008-09-30
2016-10-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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DIAGNOSTIC
NONE
Interventions
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screening questionnaire administration
computed tomography
lymphoscintigraphy
single photon emission computed tomography
intensity-modulated radiation therapy
technetium Tc 99m sulfur colloid
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Andrea L. Cheville, MD, PhD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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MC0734
Identifier Type: OTHER
Identifier Source: secondary_id
07-008292
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000611987
Identifier Type: -
Identifier Source: org_study_id
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