Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
NCT ID: NCT05989022
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
428 participants
INTERVENTIONAL
2023-11-24
2025-12-31
Brief Summary
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Detailed Description
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The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.
The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Imaging Breast Diagnostic
Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient
Injection of contrast enhancing agent Gadovist for MRI investigation
Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Injection of contrast enhancing agent Imeron for B-CT investigation
Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
Interventions
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Injection of contrast enhancing agent Gadovist for MRI investigation
Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Injection of contrast enhancing agent Imeron for B-CT investigation
Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
Eligibility Criteria
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Inclusion Criteria
2. Age: at least 18 years
3. Inconclusive findings in conventional imaging or preoperative staging or evaluation of therapy response in the neoadjuvant chemotherapy setting or imaging of the breast after breast-conserving therapy or finding the cause of hemorrhagic nipple discharge or prosthesis imaging or screening of women with hereditary or familial increased risk for the development of breast cancer or axillary lymph node metastasis suspected to originate from breast tissue
4. Persons able and willing to understand and sign informed consent form
Exclusion Criteria
2. Presence of BRCA1 or BRCA2 allele
3. Insufficient renal function (MDRD)
4. Dysfunction of the thyroid gland (TSH degradation)
5. Known allergy or intolerance against iodine-containing contrast enhancing agents or MRI contrast enhancing agents
6. Patients with paramagnetic or magnetic material inside the breast, claustrophobia
18 Years
FEMALE
Yes
Sponsors
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CRO Dr. med Kottmann GmbH & Co. KG
INDUSTRY
RQM+
INDUSTRY
AB-CT - Advanced Breast-CT GmbH
INDUSTRY
Responsible Party
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Locations
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DRZ Die Radiologen
Regensburg, Bavaria, Germany
Radiologisches Institut Universitätsklinikum Erlangen
Erlangen, , Germany
Stichting Martini Ziekenhuis
Groningen, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Countries
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Facility Contacts
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Other Identifiers
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ldBCT-MRI-C
Identifier Type: -
Identifier Source: org_study_id
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