An observational study in Breast Cancer, sponsored by Radboud University Medical Center. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Radboud University Medical Center · Observational
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 413 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Women with breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Time frame: 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).
Time frame: 3 years
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 years
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — We will evaluate the possibility to share anonimised data for future research
Start is estimated for Aug 2022; primary completion for Aug 2025, 36 months later.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 36 months is below that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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