NCT00039286

Brief Summary

RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer. PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Oct 2001

Longer than P75 for 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

Study Start

First participant enrolled

October 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

7.3 years

First QC Date

June 6, 2002

Last Update Submit

December 23, 2015

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the sensitivity, specificity, and accuracy

    2 years

Study Arms (1)

Positron Emission Tomography

EXPERIMENTAL

Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

Procedure: positron emission tomographyProcedure: radionuclide imagingRadiation: fludeoxyglucose F 18

Interventions

positron emission tomographyPROCEDURE
Positron Emission Tomography
radionuclide imagingPROCEDURE
Positron Emission Tomography
fludeoxyglucose F 18RADIATION
Positron Emission Tomography

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer for which surgical intervention is planned * Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR * Locally advanced breast cancer (T4) OR * Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR * Locally or regionally recurrent disease * No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ) * No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Not specified Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No known active infection * No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis) * Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Elisa Rush Port, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)