Our study aim is to assess whether MARIA* can provide diagnostic information that can supplement, and in some cases, replace mammography as a tool in the symptomatic workflow. We will also seek patient feedback on this non-ionising, non-compressing…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint of the study is the frequency of successful index lesion
detection, where successful is defined as *correlating to clinical findings
and/or histopathology determined by means of a needle biopsy*
Secondary outcome
-
Background summary
National breast cancer screening programs are overwhelmingly based on x-ray
mammography which, in addition to concerns over cumulative exposure risk due to
use of ionising radiation and discomfort / pain issues reported by patients, is
also known to suffer from low sensitivity in patients who exhibit partly or
exclusively dense breast tissue. In this study we will evaluate whether MARIA*,
a new breast imaging modality based on GHz-band radio-frequency technology, can
assist in the detection of lesions irrespective of breast density when applied
to a symptomatic population.
Study objective
Our study aim is to assess whether MARIA* can provide diagnostic information
that can supplement, and in some cases, replace mammography as a tool in the
symptomatic workflow. We will also seek patient feedback on this non-ionising,
non-compressing, whole-breast method of imaging,
Study design
This is a single-centre Post-Approval device study in 200 women who attend a
symptomatic clinic
Study burden and risks
Our approach allows to test the feasibility of this highly innovating approach
to breast cancer detection, with minimal negative effects or possible
complications. With respect to gains in quality of life in terms of ease and
speed of treatment, body image and recovery from treatment.
While there is no direct benefit nor detrimental effect from this study to the
patients participating, the study may have large implications for many women,
as breast cancer remains the most common cancer in women, and all currently
available techniques have clear limitations that might be overcome by MARIA.
Geert Grooteplein 10
NIJMEGEN 6525 GA
NL
Geert Grooteplein 10
NIJMEGEN 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62107.091.17 |