Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2025-12-17 @ 6:04 AM
Study NCT ID:
NCT04871139
Status:
None
Last Update Posted:
2025-07-29 00:00:00
First Post:
2021-05-01 00:00:00
Brief Title:
An Imaging Technology, Contrast-Enhanced Mammography, in Predicting Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
M.D. Anderson Cancer Center
Study Overview
Official Title:
Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
Status:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 MADs
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
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 MADs
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-0031 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-03404 | REGISTRY | None | None |