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

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: Terminated
• Conditions: Atypical Ductal Hyperplasia
• Intervention / Treatment: Device: Contrast enhanced mammography

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: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision	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

Outcome Measure	Measure Description	Time Frame
Types of Changes in Surgical Management Based on CESM	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

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Jordana Phillips, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ADH; Atypical ductal hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Hyperplasia; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID 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