Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)

High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image

Contrast Enhanced Digital Mammography

Bhavika Patel, MD

This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.

Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.

Screening CEDM in Intermediate and High-Risk Patient Populations

Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations

Number of subjects diagnosed with breast cancer

Mayo Clinic

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Galactorrhea

Breast Diseases

Skin Diseases

Lactation Disorders

Puerperal Disorders

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

Digital Tomosynthesis Mammography

Iodinated Contrast Agent

Questionnaire Administration

Olena Weaver, MD

This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.

PRIMARY OBJECTIVE:

I. To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy \[LE\] images of CESM (full field digital mammogram \[FFDM\] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ \[DCIS\], atypia, or papilloma) in patients with pathologic nipple discharge (PND).

SECONDARY OBJECTIVES:

I. To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive malignancy or DCIS in patients with PND.

II. To compare the accuracy of digital breast tomosynthesis (DBT) and LE in the detection of invasive malignancy or DCIS, as well as in the detection of the causative lesion.

III. To estimate the proportion of cases in which CESM affects the choice of the lesion targeted for a biopsy with any imaging modality.

IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CESM findings.

EXPLORATORY OBJECTIVES:

I. To evaluate the correlation of blood biomarkers and the presence of invasive cancer and DCIS on pathology in the study patients.

II. To evaluate the role of the CESM enhancement pattern in choosing a precise target for a stereotactic biopsy.

III. To evaluate the effect of CESM on the patient workflow by calculating the time from presentation to the definitive diagnosis.

IV. To evaluate the technical feasibility of using CESM- guided or CESM directed biopsies.

V. In patients who undergo a CESM targeted or CESM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.

VI. In those study patients who undergo breast MRI as a part of their clinical care, the sensitivity and specificity of magnetic resonance imaging (MRI) and CESM for the detection of causative lesions will be compared.

OUTLINE:

Patients receive iodine-based contrast agent intravenously (IV) then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study

Will be compared to low exposure (LE) images of CESM (full field digital mammogram equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ (DCIS), atypia, or papilloma) in patients with pathologic nipple discharge (PND).

M.D. Anderson Cancer Center

Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.

Lydia Liao

This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

PRIMARY OBJECTIVES:

I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).

SECONDARY OBJECTIVES:

I. Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.

II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.

EXPLORATORY OBJECTIVES:

I. To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious.

OUTLINE:

Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.

Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study

The total number of suspicious and benign lesions on each modality (mammogram+ultrasound \[MM+US\] and CEM) will be calculated and compared to a final tissue diagnosis independently.

The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.

The positive predictive value of CEM will be calculated and compared to MM+US.

The negative predictive value of CEM will be calculated and compared to MM+US.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening CEDM in Intermediate and High-Risk Patient Populations	NCT03859492	Breast Cancer	Contrast Enhanc...	35 Years -	Mayo Clinic
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge	NCT05056844	Breast Carcinom...	Contrast Enhanc... Digital Tomosyn... Iodinated Contr... Questionnaire A...	25 Years - 85 Years	M.D. Anderson Cancer Center
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings	NCT03929783	Breast Neoplasm...	Contrast Enhanc...	30 Years - 80 Years	Thomas Jefferson University
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge	NCT05056844	Breast Carcinom...	Contrast Enhanc... Digital Tomosyn... Iodinated Contr... Questionnaire A...	25 Years - 85 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for contrast enhanced digital mammography