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

NCT06280040 | Recruiting

• 1 other identifier: UM Longitudinal 1942/2022
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Retinopathy

  Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography

  1 year

Secondary Outcomes (3)

• Incidence and Severity of Opticopathy

  1 year

• Functional Outcome

  1 year

• Incidence and Severity of Retinopathy and Opticopathy in oximeter

  1 year

Study Arms (1)

Uveal Melanoma

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

Diagnostic Test: Clinical examination and multimodal ocular imaging

Interventions

Clinical examination and multimodal ocular imaging DIAGNOSTIC_TEST

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

Uveal Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.

You may qualify if:

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

You may not qualify if:

• unwillingness to participate in the study
• severe media opacity

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Ophthalmology and Optometry, Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Reinhard Told, MD, PhD

  Department for Ophthalmology and Optometry, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Kreminger, MD

CONTACT

0043 1 40400 48470; judith.kreminger@meduniwien.ac.at

Reinhard Told, MD, PhD

CONTACT

0043 1 40400 48470; reinhard.told@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: November 23, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

AU (1)