Feasibility of ultra high field 7.0 Tesla MRI for the detection of breast cancer

Completed

• Conditions: breast cancer; breast neoplasm; 10006291

• Registration Number: NL-OMON34075
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- 18 years or older
- Female patients
- A breast lesion <2cm with BIRADS 4c or higher classification on mammography, US and/or
lower field MRI
- Lesion with maximum dimension of 2 cm

Exclusion Criteria

- Any prior surgery or radiotherapy to the ipsilateral breast
- Karnofsky score <= 70
- Pregnant or lactating women
- Contra-indications to MRI scanning according to the 7T screening list of the UMCU
- Contra-indications to injection of gadolinium-based contrast-agent, including known
prior allergic reaction to any contrast-agent, and renal failure, defined by GFR <
30mL/min/1.73m2.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the 7T detection rate of stage T1 breast cancer<br /><br>lesions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the morphology of the cancer lesions as described in the MRI<br /><br>BI-RADS<br /><br>lexicon.<br /><br>- To assess the kinetics of lesion enhancement.<br /><br>- To assess the correlation of 7T MRI analysed lesions sizes to the sizes as<br /><br>determined in<br /><br>the final pathological analysis. </p><br>