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

Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Procedure: computed tomography; Radiation: technetium Tc 99m sulfur colloid; Procedure: single photon emission computed tomography; Radiation: intensity-modulated radiation therapy; Other: screening questionnaire administration; Procedure: lymphoscintigraphy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Andrea L. Cheville, MD, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage I breast cancer; lymphedema
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sulfur Colloid
• 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)