Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
|ClinicalTrials.gov Identifier: NCT03505372|
Recruitment Status : Terminated (Unable to recruit to study due to limited number of patients with ADH)
First Posted : April 23, 2018
Last Update Posted : July 2, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Atypical Ductal Hyperplasia||Device: Contrast enhanced mammography||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia|
|Actual Study Start Date :||May 10, 2018|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 28, 2019|
Experimental: Contrast enhanced mammography
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.
- CESM's ability to predict upgrade rates of biopsy proven ADH at surgical excision [ Time Frame: 2 years ]Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision
- Types of Changes in surgical management based on CESM [ Time Frame: 2 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505372
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jordana Phillips, MD||Beth Israel Deaconess Medical Center|