The aim of the study is to create and optimize a DWI MRI scan protocol to assess thymic masses.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of this study is to create and optimize a DWI MRI scan
protocol
Secondary outcome
The second objective is to assess if DWI can differentiate between different
malignant and benign thymic masses and to asses of DWI MRI can accurate
determine the invasiveness of a thymoma.
Background summary
By the increased use of Computed Tomography (CT) of the chest more asymptomatic
masses in the anterior mediastinum are found by coincidence. Asymptomatic
thymic masses found by coincidence in patients without Myasthenia Gravis
account for 42% in this population. Differentiation between malignant and
benign masses on a CT can be difficult. With the development of minimal
invasive surgery clinicians easier tend to a surgical resection. Because of
this some patients undergo a surgical procedure for benign diseases.
Diffusion Weighted Imaging (DWI) is a new technique that analysis the
differences in the cellular structures. DWI could have additive value to CT and
without the need for potentially harmful ionising radiation and nephrotoxic
contrast agents required for CT imaging. Furthermore due its suburb contrast
resolution.
Study objective
The aim of the study is to create and optimize a DWI MRI scan protocol to
assess thymic masses.
Study design
A prospective, single center pilot study.
Study burden and risks
MR sequences have a very low rate of side effects. No MR contrast agent will be
used for the assessment of the masses in the anterior mediastinum. The DWI MRI
can be arranged on the same day they will be hospitalized for preoperative
screening. This means that no extra hospital visit is needed. There is no known
risk of MRI in pregnancy, however as a precaution MRI is not recommend during
pregnancy. The MRI scan will take 10 minutes longer than regular MRI of the
thorax due to these additional sequences (in total 45 minutes). However for
this study population the treatment will not be altered on the outcome of the
DWI MRI.
P.Debyelaan 25
Maastricht 6202 AZ
NL
P.Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
• Patients >18 years old, not pregnant
• All willing patients must provide written informed consent, agree to comply with the protocol;
• Suspected for an anterior mediastinal mass arising from the thymus and accepted for robotic thymectomy
Exclusion criteria
• Patients< 18 years old
• Patients with contraindications for MRI; metal impants, pacemakers, insulin pumps and nerve stimulators
• Claustrophobia
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 | NL45378.068.13 |