- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280040
Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
March 5, 2024 updated by: Reinhard Told, Medical University of Vienna
Longitudinal Follow-Up of Retinopathy and Opticopathy After Treatment With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Judith Kreminger, MD
- Phone Number: 0043 1 40400 48470
- Email: judith.kreminger@meduniwien.ac.at
Study Contact Backup
- Name: Reinhard Told, MD, PhD
- Phone Number: 0043 1 40400 48470
- Email: reinhard.told@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Department of Ophthalmology and Optometry, Medical University Vienna
-
Contact:
- Judith Kreminger, MD
- Phone Number: 0043 1 40400 48470
- Email: judith.kreminger@meduniwien.ac.at
-
Contact:
- Reinhard Told, MD, PhD, Priv.-Doz.
- Phone Number: 0043 1 40400 48470
- Email: reinhard.told@meduniwien.ac.at
-
Sub-Investigator:
- Adrian Reumueller, MD, Priv.-Doz
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Sub-Investigator:
- Roman Dunavoelgyi, MD, Assoc.-Prof.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Uveal Melanoma
Patients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine.
|
Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and Severity of Opticopathy
Time Frame: 1 year
|
Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography
|
1 year
|
Functional Outcome
Time Frame: 1 year
|
Functional outcome will be evaluated as mean retinal sensitivity.
|
1 year
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reinhard Told, MD, PhD, Department for Ophthalmology and Optometry, Medical University of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2023
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
February 20, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UM Longitudinal 1942/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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