This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05046301.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Olena Weaver
Phone: 713-745-4555
PRIMARY OBJECTIVE:
I. To evaluate the added value of contrast enhancement of CEM compared to two dimensional (2D) mammography in predicting invasive malignancy or high-grade DCIS in patients with suspicious mammographic microcalcifications.
SECONDARY OBJECTIVES:
I. To evaluate the added value of contrast enhancement in CEM by comparing the sensitivity/specificity of contrast enhancement to the sensitivity/specificity of FFDM.
II. To evaluate whether the absence of contrast enhancement can predict the absence of high grade DCIS or invasive cancer by establishing the negative predictive value (NPV) of contrast enhancement and comparing it to the NPV of FFDM.
III To evaluate whether the presence of abnormal contrast enhancement can predict the presence of high grade DCIS or invasive malignancy by establishing the positive predictive value (PPV) of contrast enhancement and comparing it to the PPV of FFDM.
IV. To evaluate the influence of the morphology, distribution, and extent of mammographic microcalcifications on the presence and intensity of contrast enhancement.
V. 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 high-grade DCIS on pathology in the study patients.
II. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious microcalcifications equal to or exceeding 4 cm in diameter.
III. In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high grade lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
IV. 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, PPV and NPV.
OUTLINE:
Patients complete a questionnaire and undergo collection of a blood sample. Patients receive contrast intravenously (IV) and undergo CEM.
After completion of study, patients are followed for 24 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorOlena Weaver
