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

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

NCT ID: NCT05989022

Condition: Breast Cancer Diagnosis

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast CT

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Comparison between both modalities in single patients

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Injection of contrast enhancing agent Gadovist for MRI investigation
Description: Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
Arm group label: Imaging Breast Diagnostic

Intervention type: Diagnostic Test
Intervention name: Injection of contrast enhancing agent Imeron for B-CT investigation
Description: Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
Arm group label: Imaging Breast Diagnostic

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

Detailed description: The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging. 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Sex: female 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: 1. Known pregnancy or breastfeeding 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

Gender: Female

Gender based: Yes

Gender description: Only women

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Radiologisches Institut Universitätsklinikum Erlangen

Address:
City: Erlangen
Zip: 91054
Country: Germany

Status: Recruiting

Contact:
Last name: Sabine Ohlmeyer, Dr. med

Phone: +49 9131 85

Phone ext: 33460
Email: Radiologie@uk-erlangen.de

Facility:
Name: Stichting Martini Ziekenhuis

Address:
City: Groningen
Zip: 9728 NT
Country: Netherlands

Status: Recruiting

Contact:
Last name: Arnoud Meijer, MD

Phone: +31 50 524

Phone ext: 5345
Email: rontgenalgemeen@mzh.nl

Facility:
Name: Leiden University Medical Centre

Address:
City: Leiden
Zip: 2333 ZA
Country: Netherlands

Status: Recruiting

Contact:
Last name: Martin Wasser, MD

Phone: +31 71 526

Phone ext: 1840
Email: radiologieafsprakenCT-MRI@lumc.nl

Start date: November 24, 2023

Completion date: December 2025

Lead sponsor:
Agency: AB-CT - Advanced Breast-CT GmbH
Agency class: Industry

Collaborator:
Agency: CRO Dr. med. Kottmann GmbH
Agency class: Other

Collaborator:
Agency: RQM+
Agency class: Industry

Source: AB-CT - Advanced Breast-CT GmbH

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05989022