Clinical evaluation of Contrast Enhanced Breast CT to improve Staging and treatment follow up in women with breast cancer

Clinical evaluation of Contrast Enhanced Breast CT to improve Staging and treatment follow up in women with breast cancer - CEBCT vs MR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54169

Enrollment

413

Registered

2022-04-05

Start date

2023-04-18

Completion date

Unknown

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer Mamma carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Women >18 years old - Diagnoses of breast cancer - Scheduled for a pre-surgery staging contrast enhanced breast MRI - Eligible for primary systemic therapy

Exclusion criteria

Exclusion criteria: - Women with suspected or confirmed pregnancy - Women with prior breast cancer - Women who are breastfeeding - Women who are very frail and unable to cooperate - Women who cannot give informed consent - Contra indication of iodine contrast - Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer) - Male subjects

Design outcomes

Primary

Measure	Time frame
Objective a. The primary objective of this study is to perform a prospective clinical trial to compare the performance of CEBCT to that of the MRI for staging of women with breast cancer. The endpoint is a statistically significant difference in the accuracy of tumor size estimation with CEBCT and MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) resulting from independent interpretation of MRI images and the CEBCT images. Objective b. The primary objective of this study is to perform a prospective clinical trial to compare the performance of CEBCT to that of the MRI for the evaluation of residual tumor in women who have undergone primary systemic therapy. The endpoint is a statistically significant difference in the accuracy of tumor size estimation with CEBCT and MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) resulting from independent interpretation of MRI images and the CEBCT images.	—

Measure

Time frame

Objective a. The primary objective of this study is to perform a prospective clinical trial to compare the performance of CEBCT to that of the MRI for staging of women with breast cancer. The endpoint is a statistically significant difference in the accuracy of tumor size estimation with CEBCT and MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) resulting from independent interpretation of MRI images and the CEBCT images. Objective b. The primary objective of this study is to perform a prospective clinical trial to compare the performance of CEBCT to that of the MRI for the evaluation of residual tumor in women who have undergone primary systemic therapy. The endpoint is a statistically significant difference in the accuracy of tumor size estimation with CEBCT and MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) resulting from independent interpretation of MRI images and the CEBCT images.

—

Secondary

Measure	Time frame
As secondary objectives, we will record the frequency of contralateral cancers and their final pathological outcome, morphological and enhancement characteristics of cancers on CEBCT complementary to existing subtyping.	—

Countries

Netherlands

Contacts

Public ContactR. M. Mann

Radboud Universitair Medisch Centrum

ritse.mann@radboudumc.nl(024) 361 45 45

Outcome results