Clinical trial NCT05989022: Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Official title: Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Diagnosis
Keywords: Breast CT
Lead sponsor: AB-CT - Advanced Breast-CT GmbH
Sponsor class: INDUSTRY
Collaborators: name: CRO Dr. med Kottmann GmbH & Co. KG
name: RQM+
First posted: 2023-08-14
Enrollment: 428
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison between both modalities in single patients
Primary purpose: DIAGNOSTIC

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

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.

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

Primary outcomes:
measure: Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
timeFrame: one year
Secondary outcomes:
measure: Collect data for comfort of CE-BCT and CE-MRI
timeFrame: one year
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: DRZ Die Radiologen
state: Bavaria
city: Erlangen
country: Germany
facility: Radiologisches Institut Universitätsklinikum Erlangen
city: Groningen
country: Netherlands
facility: Stichting Martini Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
Study officials:
References: