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

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Device: Dedicated breast CT

Study type: Observational

Funder types: Other

Identifiers

NCT05404087

NL75855.091.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 413 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

413 participants in 2 patient groups

Pre-operative staging of breast cancer with CEBCT

Description:

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.

Treatment:

Device: Dedicated breast CT

Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy

Description:

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.

Treatment:

Device: Dedicated breast CT