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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47770

Enrollment

130

Registered

2017-05-11

Start date

2017-11-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eye tumor uveal melanoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
As secondary endpoints we will evaluate whether there are MRI findings with prognostic implications and the role of MRI in the follow-up of patients treated with ruthenium plaque therapy.	—

Countries

Netherlands

Outcome results