Clinical trial NCT05404087: Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer
Official title: Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: The Netherlands Cancer Institute
First posted: 2022-06-03
Enrollment: 413
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with breast cancer

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.

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

Primary outcomes:
measure: Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.
timeFrame: 3 years
measure: Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI.
timeFrame: 3 years
Secondary outcomes:
measure: Concordance of tumor extent between CEBCT and large section histopathology
timeFrame: 3 years
measure: Frequency of detection of contralateral cancers with CEBCT
timeFrame: 3 years
measure: Concordance between morphological and enhancement characteristics of cancers on CEBCT to their expected response to primary systemic therapy.
timeFrame: 3 years
measure: Potential of CEBCT predicting the response to primary systemic therapy early in treatment
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Radboudumc/The Netherlands Cancer Institute
name: Ritse Mann, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: