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

Recruiting

Conditions: eye tumor
uveal melanoma
10030054

Registration Number: NL-OMON47770

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

1. UM diagnosed at the LUMC
2. Age > 18 years
3. Gender: both male and female
4. Written informed consent

Exclusion Criteria

1. Contra-indication to MRI scanning:
a. Claustrophobia
b. Pregnancy
c. Pacemakers and defibrillators
d. Nerve stimulators
e. Intracranial clips
f. Intraorbital or intraocular metallic fragments
g. Cochlear implants
h. Ferromagnetic implants
i. Hydrocephalus pump
j. Permanent make-up
k. Tattoos above the shoulders
l. Piercings (unless they can be taken out)
m. Subjects who cannot keep their head still (eg. Tremor, Parkinson*s disease)
n. Severe physical restriction (completely wheelchair dependent)
o. In the case of uncertainty about the MRI-contraindications, the MR-safety
commission of the radiology department will decide whether this subject can be
included in the study.
2. Contra indication for gadolinium such as renal insufficiency or contrast
allergy.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are the MRI-based description of the tumour<br /><br>and the comparison with the conventional ultrasound description:<br /><br>1. Tumour prominence<br /><br>2. Tumour basal diameter<br /><br>3. The presence of extrascleral extension<br /><br>4. Ciliary body involvement of the tumour<br /><br>5. Radiological characteristics of UM, including signal level after contrast,<br /><br>on diffusion and perfusion.<br /><br><br /><br>7T MRI will be used as gold standard for tumour dimensions. Histological<br /><br>material will be used as gold standard for extrascleral extension, ciliary body<br /><br>involvement and for correlating radiological characteristics with the pathology.<br /><br>The 3T MRI findings will be compared to the 7T MRI findings to assess whether<br /><br>the increased resolution of the 7Tesla is needed for the evaluation of UM or<br /><br>whether they can also be performed with the images from a clinical 3Tesla<br /><br>scanner.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As secondary endpoints we will evaluate whether there are MRI findings with<br /><br>prognostic implications and the role of MRI in the follow-up of patients<br /><br>treated with ruthenium plaque therapy.</p><br>