Anatomical stability during proton beam therapy of uveal melanoma

Anatomical stability during proton beam therapy of uveal melanoma - Anatomical stability in ocular PBT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54412

Enrollment

Registered

2020-08-24

Start date

2022-11-07

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

eye tumour uveal melanoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. UM diagnosed at the LUMC 2. Undergoing proton beam therapy 3. Age > 18 years 4. Gender: both male and female 5. 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 placed before the year 2000 of less than six weeks before the MRI-scan 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.

Design outcomes

Primary

Measure	Time frame
To assess the stability of the eye, tumor and tantalum clips during the complete treatment with PBT, the following primary objectives will be studied: - The amount of inflammatory and protrusion swelling before PBT and after PBT. - The clip-clip distances before PBT and after PBT. - The clip-tumour distances before PBT and after PBT. - Tumour volume before and after treatment.	—

Secondary

Measure	Time frame
To assess the reproducibility and accuracy of MR-based geometrical measurements needed for the current planning of ocular PBT: - Clip-clip distances will be compared to calculated distances based on X-ray projections acquired during PBT. Our second secondary objective is to assess the value of bone as a reference to remove the need for clips. Therefore we will investigate the tumour-bone and clip-bone distances right before PBT and just after PBT.	—

Measure

Time frame

To assess the reproducibility and accuracy of MR-based geometrical measurements needed for the current planning of ocular PBT: - Clip-clip distances will be compared to calculated distances based on X-ray projections acquired during PBT. Our second secondary objective is to assess the value of bone as a reference to remove the need for clips. Therefore we will investigate the tumour-bone and clip-bone distances right before PBT and just after PBT.

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Countries

Netherlands

Outcome results