Uveal Melanoma - Comparative Study

Uveal Melanoma In Sonography and Color Fundus Photos - A Comparative Study

The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.

Study Overview

• Status: Recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Diagnostic test: Sonography, color fundus photography

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Reinhard Told, MD, PhD, Priv.-Doz.; Phone Number: +43 40400 79690; Email: reinhard.told@meduniwien.ac.at
• Study Contact Backup: Name: Judith Kreminger, MD; Phone Number: +43 40400 48470; Email: judith.kreminger@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna, Department of Ophthalmology and Optometry
    • Sub-Investigator: Adrian Reumueller, MD, Priv.-Doz
    • Contact: Judith Kreminger, MD; Phone Number: +4314040048470; Email: judith.kreminger@meduniwien.ac.at
    • Contact: Reinhard Told, MD, PhD, Priv.-Doz.; Phone Number: +434040079690; Email: reinhard.told@meduniwien.ac.at
    • Sub-Investigator: Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with uveal melanoma will be included in this study.

Description

Inclusion Criteria:

• Diagnosis of uveal melanoma

Exclusion Criteria:

• Inadequate or missing information on the clinical course in patient charts
• Imaging not feasible due to any reason.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uveal Melanoma; Patients with uveal melanoma will undergo a routine diagnostic imaging with color fundus photography and sonography.	Diagnostic test: Sonography, color fundus photography; Patients will undergo routine diagnostic imaging (Sonography, color fundus photography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Largest Basal Diameter	Largest Basal Diameter will be measured on echography and color fundus photography	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Reinhard Told, MD, PhD, Priv.-Doz., Deparment of Ophthalmology and Optometry

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: Uveal Melanoma 1942/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No