Breast CancerCEBCTvsMRINCT05404087
Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer
An observational study of Breast Cancer, run by Radboud University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dedicated breast CT
- Type of treatment
- Medical device
- How many people
- 413 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast cancer
Who may be able to join
- Diagnoses of breast cancer
- Scheduled for a pre-surgery staging contrast enhanced breast MRI
- Eligible for primary systemic therapy
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer
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.
Read the 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
- Being tested
- Dedicated breast CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated breast CTDevice
Administration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dedicated breast CT | |
| 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. Receives: Device: Dedicated breast CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 years
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 413 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Ritse Mann, MD-PhD, Principal investigator, Radboudumc/The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404087
- Sponsor's protocol ID
- NL75855.091.21
- Acronym
- CEBCTvsMRI
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will evaluate the possibility to share anonimised data for future research
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Contrast Enhanced Breast CT to Improve Staging and Treatment Follow up in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT05404087
- Acronym / sponsor ID
- CEBCTvsMRI / NL75855.091.21
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 413 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative staging of breast cancer with CEBCT | – | Device: Dedicated breast CTWomen 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. |
| Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy | – | Device: Dedicated breast CTWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer
Key inclusion criteria (3 listed)
- Diagnoses of breast cancer
- Scheduled for a pre-surgery staging contrast enhanced breast MRI
- Eligible for primary systemic therapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dedicated breast CTAdministration of contrast agent and scanning of the breast in order to evaluate the enhancement of the tumor | Device | Follow-up of women with breast cancer treated with neo-adjuvant chemotherapy, Pre-operative staging of breast cancer with CEBCT |
Primary outcome
Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging.
Time frame: 3 years
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.
Non-inferiority of CEBCT to predict pCR after primary systemic therapy as compared to DCE MRI.
Time frame: 3 years
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).
4 secondary outcomes
Concordance of tumor extent between CEBCT and large section histopathology
Time frame: 3 years
Frequency of detection of contralateral cancers with CEBCT
Time frame: 3 years
Concordance between morphological and enhancement characteristics of cancers on CEBCT to their expected response to primary systemic therapy.
Time frame: 3 years
Potential of CEBCT predicting the response to primary systemic therapy early in treatment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided. We will evaluate the possibility to share anonimised data for future research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritse Mann, MD-PhD principal investigator
Radboudumc/The Netherlands Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alma Hoxhaj, MD (+31 24 361 45 45, alma.hoxhaj@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of CEBCT error rate vs DCE MRI error rate, both as compared to the golden standard for tumor staging. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.