Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

NCT05989022 | Completed

• 1 other identifier: ldBCT-MRI-C
• Study Type: interventional
• Target: 293
• Locations: 2 countries
• Sites: 4

Brief Summary

Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems

Conditions

Breast Cancer Diagnosis

Keywords

Breast CT

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis

  The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis. Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.

  one year

Secondary Outcomes (1)

• Collect data for comfort of CE-BCT and CE-MRI

  one year

Study Arms (1)

Imaging Breast Diagnostic

OTHER

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

Diagnostic Test: Injection of contrast enhancing agent Gadovist for MRI investigation; Diagnostic Test: Injection of contrast enhancing agent Imeron for B-CT investigation

Interventions

Injection of contrast enhancing agent Gadovist for MRI investigation DIAGNOSTIC_TEST

Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis

Imaging Breast Diagnostic

Injection of contrast enhancing agent Imeron for B-CT investigation DIAGNOSTIC_TEST

Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis

Imaging Breast Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: female
• Age: at least 18 years
• 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
• Persons able and willing to understand and sign informed consent form

You may not qualify if:

• Known pregnancy or breastfeeding
• Presence of BRCA1 or BRCA2 allele
• Insufficient renal function (MDRD)
• Dysfunction of the thyroid gland (TSH degradation)
• Known allergy or intolerance against iodine-containing contrast enhancing agents or MRI contrast enhancing agents
• Patients with paramagnetic or magnetic material inside the breast, claustrophobia

Sponsors & Collaborators

• AB-CT - Advanced Breast-CT GmbH: lead
• CRO Dr. med Kottmann GmbH & Co. KG: collaborator
• RQM+: collaborator

Study Sites (4)

DRZ Die Radiologen

Regensburg, Bavaria, 93059, Germany

Location

Radiologisches Institut Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Stichting Martini Ziekenhuis

Groningen, 9728 NT, Netherlands

Location

Leiden University Medical Centre

Leiden, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison between both modalities in single patients

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: November 24, 2023
• Primary Completion: November 24, 2025
• Study Completion: April 22, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); DE (2)