Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia

January 30, 2020 updated by: Jordana Phillips, MD, Dana-Farber Cancer Institute

This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer.

The device involved in this study is:

-Contrast enhanced mammography

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research study is a Pilot Study, which is the first time investigators are examining this study device for this purpose.

Atypical ductal hyperplasia (ADH) is a common diagnosis after breast biopsy. Although it is not cancer itself, ADH can become breast cancer in some cases. As a result, surgery is performed to remove ADH to make sure it doesn't progress to cancer. In many cases, no cancer is found during the surgery.

Previous studies have shown that breast MRI may be able to predict which areas of ADH will be cancer at the time of surgery. This would help prevent unnecessary surgery in some patients.

Contrast enhanced mammography is a new type of mammogram that is already being used in clinical practice to help find breast cancer. Similar to breast MRI, it uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. Contrast material is a dye or other substance that helps show abnormal areas within the body.

Studies have shown the contrast enhanced mammography has a similar ability to find breast cancer as breast MRI.

The investigators purpose is to see whether contrast enhanced mammography can predict which areas of ADH will become breast cancer at the time of surgery. The investigators believe this will help prevent unnecessary surgery in many with women with the diagnosis of ADH.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age, Minimum 30 years. CESM is an imaging exam that uses radiation and is not typically employed in women younger than age 30 due to potentially negative biologic effects on glandular breast tissue.
  • Participants who had a percutaneous breast biopsy (to include stereotactic, tomosynthesis, or ultrasound guided) that revealed ADH
  • Participants will be undergoing surgical excision to remove the ADH.
  • Participants must have normal organ and marrow function as defined by a GFR ≥60 mL/min/1.73 m2 to be performed per clinical protocol
  • Patients ≥65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
  • Patients < 65 years without underlying renal insufficiency do not require an GFR calculation)
  • Patients ≥65 years with known underlying renal insufficiency get GFR tested within 1 month of the exam.
  • Patients < 65 years with known renal insufficiency get GFR tested within 1 month of the exam.
  • Because of the potential teratogenic effects of radiation, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, until the CESM is performed. Should a woman become pregnant or suspect she is pregnant, she should inform the study team prior to getting the CESM.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Participants with a core biopsy diagnosis of atypia with associated malignancy (in the same quadrant) will be excluded.
  • Participant had a breast MRI that was performed after the diagnosis of ADH but before surgical excision
  • Participants who have a known allergy to contrast media.
  • Participants who have a known severe allergic response to one or more allergens, as defined by anaphylaxis.
  • Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute.
  • Participants with renal insufficiency or failure, as determined by a point of care renal function blood test.
  • Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother.
  • Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the ACR contrast manual version 10.3 and hospital policy.
  • Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study.
  • Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm.
  • Pregnant women are excluded from this study because CESM uses radiation with the potential for teratogenic or abortifacient effects. This will be defined by a urine pregnancy test prior to the CESM study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Contrast enhanced mammography
  • The CESM images will be performed according to clinical protocol
  • Images will be acquired within approximately 2-12 minutes of contrast injection
  • A total of four images per breast will be acquired with low and high energy
  • Two radiologists will prospectively review the CESM, and will use a third as tie-breaker
  • The CESM will be evaluated for the biopsy site and up to two additional findings in either breast
  • The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement
Device: Contrast enhanced mammography
Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision
Time Frame: 3 months
Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Types of Changes in Surgical Management Based on CESM
Time Frame: 3 months
Investigators will evaluate how incidental findings seen on CESM impact the surgical management of patients diagnosed with ADH. The initial surgical management documented in the clinical report (created before CESM performed) will be compared with the surgical management documented in the medical record after the CESM was performed to determine the change.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GE Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordana Phillips, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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