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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06280040

Studienbeginn:
November 2023

Letztes Update:
06.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Melanoma, Uveal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
-

Studienleiter

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

Kontakt

Judith Kreminger, MD
Kontakt:
Phone: 0043 1 40400 48470
E-Mail: judith.kreminger@meduniwien.ac.at» Kontaktdaten anzeigen

Reinhard Told, MD, PhD
Kontakt:
Phone: 0043 1 40400 48470
E-Mail: reinhard.told@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Ophthalmology and Optometry, Medical University Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Judith Kreminger, MD
Phone: 0043 1 40400 48470
E-Mail: judith.kreminger@meduniwien.ac.at

Reinhard Told, MD, PhD, Priv.-Doz.
Phone: 0043 1 40400 48470
E-Mail: reinhard.told@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence and Severity of Retinopathy (Time Frame - 1 year):
Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography

Secondary outcome:

1. Incidence and Severity of Opticopathy (Time Frame - 1 year):
Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography

2. Functional Outcome (Time Frame - 1 year):
Functional outcome will be evaluated as mean retinal sensitivity.

3. Incidence and Severity of Retinopathy and Opticopathy in oximeter (Time Frame - 1 year):
Incidence and severity of retinopathy and opticopathy will be evaluated using oxygen saturation

Geprüfte Regime

Clinical examination and multimodal ocular imaging:
Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.

Quelle: ClinicalTrials.gov

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