Comparison of low-dose spiral breast CT with MRI in major indications of MRI for breast diagnostics

Not yet recruiting

• Conditions: Breast cancer; diagnostic imaging of the breast; 10006291; 10006232

• Registration Number: NL-OMON56808
• Lead Sponsor: AB-CT-Advanced Breast-CT GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 300

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 prosthesis imaging or
screening of women with hereditary or finding the cause of hemorrhagic nipple
discharge 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 and other exclusion criteria for MRI

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI<br /><br>in the BI-RADS detection at the lesion level in the diagnosis of<br /><br>(i) inconclusive findings in conventional imaging or<br /><br>(ii) preoperative staging or<br /><br>(iii) evaluation of therapy response in the neoadjuvant chemotherapy setting or<br /><br>(iv) occult primary breast carcinoma or<br /><br>(v) prosthesis imaging or<br /><br>(vi) screening of women with familial increased risk for the development of<br /><br>breast cancer or<br /><br>(vii) finding the cause of hemorrhagic nipple discharge or<br /><br>(viii) axillary lymph node metastasis suspected to originate from breast<br /><br>tissue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to collect data for comfort of CE-BCT and CE-MRI<br /><br>using a patient questionnaire of closed questions. </p><br>