NCT03505372

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Atypical Ductal Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-10
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2018-04-23
• Last updated: 2020-02-11
• Results posted: 2020-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study