NCT00743314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1 breast-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

8.1 years

First QC Date

August 27, 2008

Last Update Submit

October 4, 2018

Conditions

Breast CancerLymphedema

Keywords

lymphedemastage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

screening questionnaire administrationOTHER
computed tomographyPROCEDURE
lymphoscintigraphyPROCEDURE
single photon emission computed tomographyPROCEDURE
intensity-modulated radiation therapyRADIATION
technetium Tc 99m sulfur colloidRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Radiotherapy, Intensity-ModulatedTechnetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsSulfur CompoundsInorganic ChemicalsTechnetium Compounds

Study Officials

  • Andrea L. Cheville, MD, PhD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

US(1)