To test the feasibility of breast MR elastography and explore the viscoelastic parameters of (1) normal breast tissue, of (2) breast tumours and of (3) scar tissue in the breast after lumpectomy.
ID
Source
Brief title
Condition
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The viscosity and elasticity (kPa) of normal breast tissue, of breast tumours
and of the post-operative breast tissue.
Secondary outcome
NA
Background summary
MR Elastography can be used to obtain biomechanical information (elasticity,
viscosity) of tissue by measuring and displaying propagating mechanical waves.
Alteration of tissue biomechanics plays a central role in disease processes.
Currently, breast MR imaging does not involve the evaluation of tissue
biomechanics.
Study objective
To test the feasibility of breast MR elastography and explore the viscoelastic
parameters of (1) normal breast tissue, of (2) breast tumours and of (3) scar
tissue in the breast after lumpectomy.
Study design
Single-centre, non-randomised prospective exploratory imaging study.
Study burden and risks
For all participants, participating in this study will be entirely
non-invasive: for the MRI no contrast agent will be administered.
Patients with a breast tumor (group 2) will have the MR elastography scan added
to the breast MRI which they will receive as part of standard care. The total
time of the MRI will therefore be 40 instead of 30 minutes.
Participants from group 1 and 3 (volunteers and patients after lumpectomy) will
have additional anatomical MR series in addition to the MR elastography scan,
without the administration of constrast agent. The time in the MRI will be
approximately 30 minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Female, 18 years of age or older.
* Healthy volunteer with no medical history with respect to the breast (group 1), known breast cancer (group 2) or history of lumpectomy (group 3).
* The capacity to understand the patient information sheet and the ability to provide written informed consent.
Exclusion criteria
- Standard contraindications to MR imaging (e.g. cardiac pacemaker, cochlear implant, claustrophobia, pregnancy).
- Known chronic kidney disease (for those patients who will receive the standard breast MRI with Gadolinium for the purpose of this study and not as part of routine care).
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 | NL52963.018.15 |