Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma

Study Purpose

The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.

Exclusion Criteria:

  • - unwillingness to participate in the study.
- severe media opacity

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06280040
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Vienna
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Reinhard Told, MD, PhD
Principal Investigator Affiliation Department for Ophthalmology and Optometry, Medical University of Vienna
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Austria
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Uveal Melanoma
Arms & Interventions

Arms

: Uveal Melanoma

Patients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine.

Interventions

Diagnostic Test: - Clinical examination and multimodal ocular imaging

Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vienna, Austria

Status

Recruiting

Address

Department of Ophthalmology and Optometry, Medical University Vienna

Vienna, , 1090

Site Contact

Judith Kreminger, MD

[email protected]

0043 1 40400 48470

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