Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing
18 Years
N/A
Both
Breast Cancer, Lymphedema
Trial Information
Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing
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 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration
Safety Issue:
No
Principal Investigator
Andrea L. Cheville, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000611987
NCT ID:
NCT00743314
Start Date:
September 2008
Completion Date:
Related Keywords:
- Breast Cancer
- Lymphedema
- lymphedema
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
- Lymphedema
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
