Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05989022 | RECRUITING | Breast Cancer Diagnosis

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

AB-CT - Advanced Breast-CT GmbH

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

Condition or disease

Breast Cancer Diagnosis

Intervention/treatment

Injection of contrast enhancing agent Gadovist for MRI investigation

Injection of contrast enhancing agent Imeron for B-CT investigation

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 428 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Actual Study Start Date : 2023-11-24
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

Location Details

NCT05989022

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Germany, Bavaria

DRZ The radiologists

Regensburg, Bavaria, Germany, 93059

RECRUITING

Germany,

Radiological Institute Erlangen University Hospital

Erlangen, Germany, 91054

RECRUITING

Netherlands,

Martini Hospital Foundation

Groningen, Netherlands, 9728 NT

RECRUITING

Netherlands,

Leiden University Medical Centre

Leiden, Netherlands, 2333 FOR