Clinical trial NCT04871139: An Imaging Technology, Contrast-Enhanced Mammography, in Predicting Breast Cancer
Official title: Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the added value of contrast enhancement of contrast-enhanced mammography (CEM) compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortion (MAD)s.

SECONDARY OBJECTIVES:

I. To compare sensitivity, specificity, negative predictive value and positive predictive value of CEM versus FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS in patients with suspicious MADs.

II. To evaluate whether the presence of enhancement on CEM correlates with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy.

III. To estimate the proportion of cases in which CEM changes the original target for a stereotactic biopsy.

IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM 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 CEM enhancement pattern in choosing a precise target for a stereotactic biopsy.

III. To develop an objective method of quantifying the degree of enhancement above background using AI-based digital image analysis.

IV. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious MADs.

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

VI. To compare the performance of FFDM (obtained as a part of the recent prior screening or diagnostic mammographic work-up) and LE CEM images (obtained as a part of the CEM study) in terms of accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the detection of invasive cancer and high-grade DCIS.

OUTLINE:

Patients receive iodine-based contrast agent intravenously (IV) and the undergo CEM over 10-15 minutes.

Eligibility criteria: Inclusion Criteria:

* Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
* Age 25-85 years
* Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent

Exclusion Criteria:

* Reported history of an allergic reaction to iodinated contrast
* History of anaphylactic reaction to any substance
* Renal insufficiency
* Pregnancy or lactation within 6 months
* Breast surgery affecting the site of interest within prior 6 months
* Breast biopsy at the site of interest within the last 2 months

Primary outcomes:
measure: Accuracy of contrast-enhanced mammography (CEM)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS
timeFrame: Up to 3 years
measure: Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
timeFrame: Up to 3 years
measure: Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
timeFrame: Up to 3 years
measure: Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
timeFrame: Up to 3 years
measure: Degree of enhancement on CEM
timeFrame: Up to 3 years
measure: Proportion of cases in which CEM changes the original target for a stereotactic biopsy
timeFrame: Up to 3 years
measure: Cancer detection rate
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Olena Weaver
role: PRINCIPAL_INVESTIGATOR
References: