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

NCT03505372 | Terminated Results DMC FDA Device

• 1 other identifier: 17-694
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atypical Ductal Hyperplasia

Keywords

Atypical ductal hyperplasia; ADH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Types of Changes in Surgical Management Based on CESM

  3 months

Study Arms (1)

Contrast enhanced mammography

EXPERIMENTAL

* 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

Interventions

Contrast enhanced mammography DEVICE

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.

Contrast enhanced mammography

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• GE Healthcare: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Dr Jordana Phillips
• Organization: Beth Israel Deaconess Medical Center

jphilli2@bidmc.harvard.edu

617 667 1630

Study Officials

• Jordana Phillips, MD

  Beth Israel Deaconess 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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 23, 2018
• Study Start: May 10, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)