Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.

Contrast-Enhanced Mammography

Digital Tomosynthesis Mammography

Electronic Health Record Review

Iodinated Contrast Agent

Olena Weaver

This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.

PRIMARY OBJECTIVE:

I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram \[FFDM\] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.

SECONDARY OBJECTIVES:

I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.

II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.

III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.

EXPLORATORY OBJECTIVES:

I. To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.

II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.

III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.

OUTLINE:

Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.

After completion of study treatment, patients are followed up for 12 months.

Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion

Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center

Defined as the number of concordant cases between CEM/low energy (LE) and pathologic evaluation divided by the total sample size. Will be estimated along with 95% confidence intervals; and compared between the modalities using the McNemar test or the weighted generalized score statistic proposed by Kosinski, if deemed appropriate. To account for multiple lesions, outcome variables will be analyzed using generalized liner mix models or extended McNemar's test, and additional analyses may be further performed if deemed appropriate.

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Galactorrhea

Lactation Disorders

Puerperal Disorders

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

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.

Contrast Enhanced Digital Mammography

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion	NCT05036083	Breast Carcinom... Invasive Breast...	Contrast-Enhanc... Digital Tomosyn... Electronic Heal... Iodinated Contr...	18 Years -	M.D. Anderson Cancer Center
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 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

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