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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

Primary Purpose

Breast Cancer, Lymphedema

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
screening questionnaire administration
computed tomography
lymphoscintigraphy
single photon emission computed tomography
intensity-modulated radiation therapy
technetium Tc 99m sulfur colloid
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring lymphedema, stage I breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2008
Last Updated
October 4, 2018
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00743314
Brief Title
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
Official Title
Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema
Keywords
lymphedema, stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Masking
None (Open Label)
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
screening questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
lymphoscintigraphy
Intervention Type
Procedure
Intervention Name(s)
single photon emission computed tomography
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
technetium Tc 99m sulfur colloid
Primary Outcome Measure Information:
Title
Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration
Title
Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®
Title
Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy
Title
Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L. Cheville, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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