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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00743314
First received: August 27, 2008
Last updated: October 12, 2016
Last verified: April 2016
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: September 2008
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743314

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Andrea L. Cheville, MD, PhD Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00743314     History of Changes
Other Study ID Numbers: CDR0000611987
P30CA015083 ( U.S. NIH Grant/Contract )
MC0734 ( Other Identifier: Mayo Clinic Cancer Center )
07-008292 ( Other Identifier: Mayo Clinic IRB )
Study First Received: August 27, 2008
Last Updated: October 12, 2016

Keywords provided by Mayo Clinic:
lymphedema
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 20, 2017