NCT00896649

Brief Summary

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors. PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable 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

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

May 9, 2009

Results QC Date

May 6, 2016

Last Update Submit

April 3, 2017

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography

    Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant

    immediately at completion of mammogram

Secondary Outcomes (1)

  • Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study

    One month

Study Arms (1)

positron emission mammography

EXPERIMENTAL

questionnaire administration digital mammography positron emission mammography

Other: questionnaire administrationProcedure: digital mammographyProcedure: positron emission mammography

Interventions

questionnaire administrationOTHER

Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.

positron emission mammography
digital mammographyPROCEDURE

standard screening mammogram

positron emission mammography
positron emission mammographyPROCEDURE

one-time positron emission mammography to compare recall rates with that of standard mammogram

positron emission mammography

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:
  • Dense breast tissue
  • At high-risk for breast cancer
  • PATIENT CHARACTERISTICS:
  • Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:
  • Hispanic
  • Haitian Creole
  • African American
  • Caucasian
  • PRIOR CONCURRENT THERAPY:
  • None specified

You may not qualify if:

  • No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Gustavo Mercier, House Radiologist
Organization
Boston Medical Center
gustavo.mercier@bmc.org
617-638-6610

Study Officials

  • Gustavo Mercier, MD, PhD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: PEM
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Attending Physician

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2012

Study Completion

January 1, 2017

Last Updated

May 9, 2017

Results First Posted

October 31, 2016

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Individual participant data is not useful.

Locations

US(1)