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Radiowave radar imaging for breast cancer detection * a feasibility study

Withdrawn
Conditions
breast cancer
breast lesions
10006291
Registration Number
NL-OMON44205
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

* Female sex.
* 19 years or older.
* Symptomatic breast lesion
* Able to provide informed consent.

Exclusion Criteria

* Male sex.
* 18 years or younger.
* Unable to provide informed consent.
* Unable to lie in the prone position
* Patients who have undergone biopsy less than 5 days before the MARIA* scan
* Patients with implanted electronics.
* Patients with nipple piercings (unless they are removed prior to the MARIA* scan)
* Breast sizes smaller than AA or greater than 1L in volume

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main endpoint of the study is the frequency of successful index lesion<br /><br>detection, where successful is defined as *correlating to clinical findings<br /><br>and/or histopathology determined by means of a needle biopsy* </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>-</p><br>
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