Clinical trial · Observational
Vascular Response to Brachytherapy Using Functional OCT
Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography
NCT01955941CI-TRIAL-00067530completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Patients with uveal melanoma for which brachytherapy is recommended will be considered and evaluated for enrollment into this study in order to describe the association between radiation treatment and changes in vision and blood flow within these treated eyes. Changes in vision and blood flow will be monitored at yearly intervals over a 5-year period. Up to 60 subjects will be recruited for this group.
- label
- Cohort B
- description
- Patients with uveal melanoma who have previously undergone I-125 plaque brachytherapy will be considered for enrollment into this study to evaluate blood flow in eyes with more advanced radiation-induced changes. This group will only undergo a one-time study session. Up to 40 subjects will be recruited for this group.
Primary outcomes (2)
- measure
- Blood flow pattern changes in uveal melanoma patients after radiation treatment (Cohort A)
- timeFrame
- 60 months
- description
- The purpose of this study is to learn how blood flows to tumors in important structures of the eye in patients treated with I-125 plaque brachytherapy for uveal melanoma. This will be assessed using Doppler OCT and OCT angiography technologies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy. Exclusion Criteria: * Inability to give informed consent. * Inability to maintain stable fixation for OCT imaging * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant * A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). * Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible. * Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.
References
Publications (0)
Data not yet available
No reference posted for this study.