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

NCT ID: NCT05404087

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 413 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-08-01

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Dedicated breast CT

Intervention Type: DEVICE

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.

Dedicated breast CT

Intervention Type: DEVICE

Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

Interventions

Dedicated breast CT

Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ritse Mann, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Radboudumc/The Netherlands Cancer Institute

Central Contacts

Alma Hoxhaj, MD

Role: CONTACT

alma.hoxhaj@radboudumc.nl

+31 24 361 45 45

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NL75855.091.21

Identifier Type: -

Identifier Source: org_study_id