Skip to content

MRI for brachytherapy of Uveal Melanoma patients

MRI for brachytherapy of Uveal Melanoma patients - MRI for brachytherapy in Uveal Melanoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51655
Enrollment
40
Registered
2022-07-24
Start date
2022-11-25
Completion date
Unknown
Last updated
2024-08-19

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

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of primary UM 2. UM lesions arising from the choroid or ciliary body 3. No history of previous UM treatments 4. UM patients who will be treated with brachytherapy 5. Tumor prominence >3 mm

Exclusion criteria

Exclusion criteria: 1. Subjects who are not legally capable 2. Subjects under the age of 18 3. Contraindications to MRI scanning, including: o Claustrophobia o Pregnancy o Pacemakers and defibrillators o Nerve stimulators o Intracranial clips o Metallic fragments o Cochlear implants o Ferromagnetic implants o Hydrocephalus pump o Permanent make-up o Tattoos above the shoulders o Subjects who cannot keep their head still (eg. Tremor, Parkinson*s disease) o Severe physical restriction (eg. 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 or not. 4. Contra indication for gadolinium such as renal insufficiency or contrast allergy

Design outcomes

Primary

MeasureTime frame
1. Tumor dimensions: Prominence, largest basal diameter, second basal diameter. 2. Changes in tumor dimensions, volume between the different time points. 3. Tumor apparent diffusion coefficient (ADC), time-intensity curve (TIC), pharmacokinetic parameters (Ktrans, Ve, Vp).

Secondary

MeasureTime frame
Additional changes in the radiological appearance of the UM on MRI, such as: • Signal on T1 and T2 (measured relative to the choroid and eye muscle respectively) • Homogeneity of the lesion • Presence of retinal detachment • Localization compared to FAF

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)