Assessment of the value of Magnetic Resonance Imaging in diagnosis and treatment planning for Uveal Melanoma

Uveal melanoma (UM) is the most common malignant primary tumour of the eye in
the adult.
The Leiden University Medical Center (LUMC) is the National Expertise Center
for the diagnosis and treatment of UM in the Netherlands, with about 200
patients per year being referred.
The decision between an eye preserving therapy and enucleation (removal of the
eye) is primarily based on the tumor dimensions and location. At the moment 2D
Ultrasound (US) is the standard exam performed for this evaluation. However,
Magnetic Resonance Imaging (MRI), given its high spatial resolution, 3D imaging
capabilities and high intrinsic contrast provides important additional clinical
information. In LUMC a 7T MRI has been performed in 10 patients as
ophthalmologists had doubts about the accuracy of the 2D ultrasound
measurements of these patients. The high-resolution 3D MRI images of the eye,
changed in 2 patients the treatment plan, making them still eligible for
eye-preserving therapy, whereas according to the US measurements they would
need to be enucleated.

With this study we aim to improve the current ocular MRI protocols and assess
its additional value in the diagnosis and therapy planning of UM.
1. Extend the current 7T MRI protocols to provide information to differentiate
tumour types.
2. Translate these protocols to the clinical 3T MRI.
3. Assess the added value of 3D MR-images from 3T MRI and 7T MRI on measuring
the tumour dimensions when compared to 2D US.
4. Assess the added value of 3T MRI and 7T MRI to evaluate extrascleral
extension of the tumour, compared to the clinical US evaluation.
5. To evaluate whether MRI can non-invasively classify different types of UM.
6. To assess the added value of MRI in the evaluation of tumour response to
ruthenium plaque brachytheraphy and proton therapy treatment.

The study is a single center cross-sectional study to evaluate the value of MRI
in the characterization of UM. The study will consist of four different groups
of a total of 130 patients, one for MRI protocol development, one for the
comparison with conventional US, one to compare image characteristics on MRI
with histologic characterization in enucleated eyes and the other one to assess
the value of a follow-up MRI to evaluate treatment response in patients treated
with ruthenium plaque therapy.
The subjects will undergo a MRI scan protocol both at 3T and/or 7T MRI scanner.
These data will be compared with the standard clinical evaluations, such as US,
and for the patients whose eye will be enucleated, with histological material.

Fourty subjects will undergo two MRI scan protocols (at a 3T and 7T MRI
scanner) on two different days. Thirty patients will undergo four MRI scan
protocols (either 3 or 7T) at 1, 3, 6, 12 months after treatment and sixty
patients will undergo one 3T MRI scan.
The MRI protocol includes the use of a gadolinium based contrast agent and each
takes less than 60 minutes.
The risks are the ones associated with MRI and with the injection of a
gadolinium-contrast agent. Safety is evaluated by carefully questioning each
subject for MRI contraindications and by checking the renal function to keep
the risk associated with participation at minimal.