Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer (CEBCTvsMRI)

Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer

Contrast-enhanced breast CT is a novel high resolution and fully 3D imaging method to document abnormalities within the breast. I will establish its value for breast cancer staging and in monitoring therapy response.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Dedicated breast CT

Detailed Description

Breast CT is a novel modality that has not been largely evaluated in a clinical setting. Only recently FDA and CE marked BCT machines have been released, and the number of installed bases internationally is below 10 (although rapidly rising).

Internationally only a few studies on contrast enhanced breast CT have been performed in small numbers of patients, albeit with excellent results. Nevertheless, substantial evidence for this novel modality is still absent. In particular, the correlation of enhancement and histological grade of DCIS, correlation of CEBCT findings with histopathology, and prediction and assessment of primary systemic treatment are open fields for which more substantial evaluation is clearly needed. In this study we want to establish the value of CEBCT in staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS), and in the evaluation of women treated with primary systemic therapy.

• Study Type: Observational
• Enrollment (Anticipated): 413

Contacts and Locations

• Study Contact: Name: Alma Hoxhaj, MD; Phone Number: +31 24 361 45 45; Email: alma.hoxhaj@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with breast cancer

Description

Inclusion Criteria:

• Diagnoses of breast cancer
• Scheduled for a pre-surgery staging contrast enhanced breast MRI
• Eligible for primary systemic therapy

Exclusion Criteria:

• Women with suspected or confirmed pregnancy
• Women with prior history of 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 (i.e. untreatable contrast allergy, renal function impairment (GFR <60 ml/min/1.73m2))
• Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer)
• Male subjects

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-operative staging of breast cancer with CEBCT; Women who have been diagnosed with breast cancer and need to have a pre-operative staging and this will be done with contrast-enhanced breast CT.	Device: Dedicated breast CT; Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor
Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy; Women who are selected for neo-adjuvant chemotherapy to reduce the size of the tumor need to be followed-up in order to evaluate the treatment response.	Device: Dedicated breast CT; Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.	Non-inferiority of CEBCT error rate against the golden standard, i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging. i.e. histopathology, to DCE MRI error rate against the golden standard for tumor staging.	3 years
Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI.	Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI computed from the area under the receiver operating characteristic (ROC) curve (AUC) (or AUROC).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of tumor extent between CEBCT and large section histopathology	We will evaluate the rate of concordance between the size of the tumour determined at CEBCT images and those at final histopathology sections	3 years
Frequency of detection of contralateral cancers with CEBCT	We will record how many times we will find a contralateral incidental breast cancer, not previously reported, after performing CEBCT	3 years
Concordance between morphological and enhancement characteristics of cancers on CEBCT to their expected response to primary systemic therapy.	We will evaluate the rate of concordance of breast cancer response to primary systemic therapy compared to the expected response based on literature by evaluating their morphological and enhancement characteristics at CEBCT examinations	3 years
Potential of CEBCT predicting the response to primary systemic therapy early in treatment	We will assess the potential of CEBCT in predicting the response of breast cancer to primary systemic therapy as compared to the assessment made at final histopathology section	3 years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Ritse Mann, MD-PhD, Radboudumc/The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NL75855.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will evaluate the possibility to share anonimised data for future research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes