Uveal MelanomaNCT01955941
Vascular Response to Brachytherapy Using Functional OCT
An observational study of Uveal Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 22 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will measure blood flow changes in 28 patients with uveal melanoma requiring radiation therapy.
Who may be able to join
- Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography
The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.
Read the detailed description
Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.
In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.
- Conditions
- Uveal Melanoma
- Keywords
- Uveal melanoma, brachytherapy, radiation, ciliary body, choroid, I-125 plaque brachytherapy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | 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. | |
| Cohort B | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow pattern changes in uveal melanoma patients after radiation treatment (Cohort A)
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.
Measured: 60 months
Blood flow pattern changes in uveal melanoma in eyes with more advanced radiation-induced changes (Cohort B)
Describe changes over time in tumor vascularity and vascular caliber as measured by OCT angiography in eyes that have already undergone I-125 plaque therapy and demonstrate signs of radiation-induced changes.
Measured: 1 study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Skalet, Oregon Health and Science University
- Investigators
- Alison Skalet, MD, PhD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955941
- Sponsor's protocol ID
- IRB00009501
- Other IDs
- IRB#00009501
- Status last verified
- Jun 2023
- First submitted
- 30 Sep 2013
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01955941
- Acronym / sponsor ID
- IRB00009501
- Conditions
- Uveal Melanoma
- Keywords
- Uveal melanoma, brachytherapy, radiation, ciliary body, choroid, I-125 plaque brachytherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.
Detailed description
Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.
In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –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. |
| Cohort B | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will measure blood flow changes in 28 patients with uveal melanoma requiring radiation therapy.
Key inclusion criteria (1 listed)
- Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood flow pattern changes in uveal melanoma patients after radiation treatment (Cohort A)
Time frame: 60 months
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.
Blood flow pattern changes in uveal melanoma in eyes with more advanced radiation-induced changes (Cohort B)
Time frame: 1 study session
Describe changes over time in tumor vascularity and vascular caliber as measured by OCT angiography in eyes that have already undergone I-125 plaque therapy and demonstrate signs of radiation-induced changes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Uveal Melanoma
RecruitingPhase 2
HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）
Melanoma (Excluding Uveal Melanoma)
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
RecruitingObservational study
Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome
Uveal Melanoma, Cutaneous Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Skalet, MD, PhD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveal Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow pattern changes in uveal melanoma patients after radiation treatment (Cohort A) (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.