Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Hyperplasia

Carcinoma

Carcinoma, Intraductal, Noninfiltrating

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

* 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

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

Jordana Phillips, MD

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

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.

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

Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.

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.

GE Healthcare

Dana-Farber Cancer Institute

Principal Investigator

* 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

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.

Contrast Enhanced Mammography

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Patients who had ADH and were getting surgical excision were enrolled. We terminated the study as recruitment was too low to continue.

Dr Jordana Phillips

Images were performed but outcome data was not collected and therefore we cannot provide any analysis.

CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision

Types of Changes in Surgical Management Based on CESM

Overall Study

Carcinoma, Ductal

Carcinoma, Lobular

Precancerous Conditions

Breast Diseases

Skin Diseases

Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.

Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).

Ruxolitinib

Placebo (for Ruxolitinib)

Kristen Otte

Shelley Hill

Catherine Parker, MD

Versie Barnes

Carla Fisher, MD

Anton Lulaj

Sheldon Feldman, MD

Crissey Tait

Kristalyn Gallagher, DO

Clinical Trials Information Program

Ingrid Meszoely, MD

Claudette Foreman

Julie Nangia, M.D.

Mothaffar Rimawi, M.D.

Bora Lim, M.D.

C. Kent Osborne, M.D.

Diane Weber, RN

Parijatham Thomas, MD

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

Ruxolitinib for Premalignant Breast Disease

TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions

The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo.

To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo

Incyte Corporation

Translational Breast Cancer Research Consortium

Julie Nangia

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute
Ruxolitinib for Premalignant Breast Disease	NCT02928978	Ductal Carcinom... Atypical Lobula... Atypical Ductal... Lobular Carcino...	Ruxolitinib Placebo (for Ru...	18 Years -	Baylor Breast Care Center
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia	NCT03505372	Atypical Ductal...	Contrast enhanc...	30 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for adh

Every month we try and update this database with for adh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adh

Every month we try and update this database with for adh cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adh cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.