Primary goal: determine the diagnostic quality of CE-MRI scans acquired in supine positionSecundary goal: determine the accuracy of deformable image registration between prone CE-MRI and non-CE-MRI in supine position as an alternative option
ID
Source
Brief title
Condition
- Other condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Health condition
Borst diagnostisch verrichting
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal, diagnostic quality of supine CE-MRI, will be evaluated by 4
radiologists. Each will compare the diagnostic quality with the prone CE-MRI in
terms of supine is: better, equal or worse. The image quality of the supine
scan will visually be judged on visibility of the lesion extent, in categories,
excellent, reasonable, dubious, and impossible.
Secondary outcome
The secondary parameter is the accuracy of deformable image registration
between prone CE-MRI scans and supine non-CE-MRI scans. Registration accuracy
will be assessed by defining a set of corresponding anatomical landmarks in
both images before registration. After registration, the distance between
corresponding anatomical landmarks defines the registration accuracy. The
identification of landmarks will be performed by two radiologists. The first
radiologist will define the landmarks on both the prone and the supine scan.
The second radiologist will be provided with the landmarks of the other
radiologist on the prone scan, and define the corresponding landmarks on the
supine scan. An ANOVA method will be used to define registration accuracy,
taking into account observer variation.
Background summary
Women with early stage breast cancer are generally treated with breast
conserving therapy. This treatment consists of surgical removal of the lesion
with a resection margin, followed by radiotherapy. In cases with (a component
of) ductal carcinoma in-situ (DCIS) or invasive lobular carcinoma (ILC) the
lesion is non-palpable in approximately 80% of patients, hampering the surgical
procedure. To guide the surgeon, a contrast enhanced MRI (CE-MRI) is acquired
to establish lesion location and extent. Furthermore, a radioactive marker is
implanted in the lesion for guidance during surgery. Despite these measures,
positive resection margins still occur in approximately 20% of patients.
This pilot study is part of a larger study investigating the possibilities of
marking the outer border of the resection area preoperatively using multiple
markers. We hypotisize that this could lead to more radical resetions.
CE-MRI scans are generally acquired in prone position, to minimize the
influence of breathing motion on the image quality. However, marker insertion
and surgery are always performed in supine position. This orientation
difference results in an CE-MRI which is anatomically not fully representative
for the setup of the interventions.
The goal of this pilot study is to achieve CE-MRI scans in supine position with
good diagnostic quality.
Study objective
Primary goal: determine the diagnostic quality of CE-MRI scans acquired in
supine position
Secundary goal: determine the accuracy of deformable image registration between
prone CE-MRI and non-CE-MRI in supine position as an alternative option
Study design
Within this study patients wil undergo one extra MR imaging session
preoperatively. Within this session two MR scans will be acquired in supine
position, first without contrast enhancement, subsequently with contrast
enhancement. After the imaging session the study participation is finalized for
the patient.
Study burden and risks
The burden for the patient is one extra MR imaging session which will take
approximately 30 minutes. Also one extra administration of gadolinium contrast
is part of the burden. The risks are assessed to be negligible.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Histological proven invasive breast cancer with a DCIS (component) or pure ILC
Schedule for breast conserving therapy
A diagnositic contrast enhance MRI in prone position
Informed consent
><= 18 years old
Exclusion criteria
Contra indication for MRI
Contra indication for gadolinium contrast administration
Design
Recruitment
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 | NL45779.031.13 |