Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI

NCT02770586

Breast Cancer

COMPLETED NA

A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening

NCT00462891

Breast Cancer

COMPLETED NA

Biennial CEM in Women With a Personal History of Breast Cancer

NCT06105749

Breast Cancer Breast Neoplasms Breast Cancer Female +1 more

RECRUITING NA

Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

NCT03176979

Breast Carcinoma

COMPLETED NA

Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer

NCT01716247

Women at Increased Risk for Developing Breast Carcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration.
* To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography.
* To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain.

OUTLINE: Patients undergo a conventional two-view mammogram and positron emission mammography (PEM). Immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography.

After completion of study treatment, patients are followed annually.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

PEM

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

positron emission mammography

questionnaire administration digital mammography positron emission mammography

Group Type EXPERIMENTAL

questionnaire administration

Intervention Type OTHER

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

digital mammography

Intervention Type PROCEDURE

standard screening mammogram

positron emission mammography

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire administration

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

Intervention Type OTHER

digital mammography

standard screening mammogram

Intervention Type PROCEDURE

positron emission mammography

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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