Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer

Breast Cancer Clinical Trial

— CEBCTvsMRI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05404087
• Other study ID #: NL75855.091.21
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: Alma Hoxhaj, MD
• Phone: +31 24 361 45 45
• Email: alma.hoxhaj[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 413
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Dedicated breast CT
Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	The Netherlands Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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