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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00743314
First received: August 27, 2008
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration [ Designated as safety issue: No ]
  • Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT® [ Designated as safety issue: No ]
  • Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy [ Designated as safety issue: No ]
  • Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Primary Completion Date: December 2012 (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 and older
Genders Eligible for Study:   Both
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
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Andrea Cheville, M.D., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00743314     History of Changes
Other Study ID Numbers: CDR0000611987, P30CA015083, MC0734, 07-008292
Study First Received: August 27, 2008
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on June 17, 2013