A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)NCT02043470
Retinal Oxygen Function After Radiation Therapy
An observational study of A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s), run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 4 May 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a history of radiation therapy for a tumor in the vicinity of the retina(s) at the Department of Radiation Oncology, UNC-CH.
Who may be able to join
- ≥ 18 years of age at the time of radiation therapy (no upper age limit)
- History of radiation therapy delivered at UNC-CH or Rex Hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment
- Estimated average dose to at least one quadrant of one retina ≥ 30 Gy
Who cannot join
- History of diabetes, retinal vascular occlusions, glaucoma, retinitis pigmentosa, occipital stroke or any other ophthalmologic or systemic problem that may confound visual field results.
- Residual tumor within the visual pathway: retina, optic nerves, optic chiasm, optic radiations and brain.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology Clinic
Chapel Hill, North Carolina, 27599
About this study
Official title: Changes in Regional Retinal Oxygen Extraction and Function After Radiation Therapy
The investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). Since different regions of retina receive different radiation doses, the investigators will assess for a dose response as well.
Read the detailed description
Radiation therapy (RT) is a common treatment for patients with cancers of the sinonasal area, orbit, skull base, nasopharynx, and brain. Because of the close proximity of these targets to the eyes, the retina is often incidentally and unavoidably irradiated. As a result, some patients develop radiation retinopathy and possibly vision loss. Clinicopathologic studies suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small vessel occlusion and ischemia that can lead to neovascularization, increased capillary permeability, and visual loss in the regions of retina perfused by damaged vasculature. UNC has a novel, non-invasive retinal imaging technology called a Retinal Oximeter which measures hemoglobin oxygen saturation of retinal vessels. The difference in oxygen saturation between a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region supplied by that vessel pair.
- Keywords
- Sinus/nasal cancer
- Medical subject headings
- Fistula, Nose Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormalities in regional retinal oxygen extraction after incidental irradiation of the retina.
To identify abnormalities in regional retinal oxygen extraction in patients who have had previous incidental irradiation of the retina.
Measured: 2 months
Prevalence of vision loss in patients with previous incidental irradiation of the retina
To determine the prevalence of regional retinal dysfunction (i.e. vision loss) in patients with previous incidental irradiation of the retina.
Measured: 2 months
Secondary outcomes (3)
Changes in retinal oxygen extraction compared to radiation dose
To correlate changes in retinal oxygen extraction to radiation dose.
Measured: 2 months
Vision loss amount versus radiation dose.
To correlate retinal dysfunction (i.e. vision loss) to radiation dose.
Measured: 2 months
Changes in retinal oxygen extraction as compared to vision loss.
To correlate changes in retinal oxygen extraction to retinal dysfunction (i.e. vision loss).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Translational and Clinical Sciences (Tracs)
- Responsible party
- Sponsor
- Investigators
- Bhishamjit Chera, MD, Principal investigator, Department of Radiation Oncology, University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043470
- Sponsor's protocol ID
- LCCC 1019
- Status last verified
- May 2017
- First submitted
- 13 Jan 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Regional Retinal Oxygen Extraction and Function After Radiation Therapy
- ClinicalTrials.gov ID
- NCT02043470
- Acronym / sponsor ID
- LCCC 1019
- Keywords
- Sinus/nasal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- UNC Translational and Clinical Sciences (Tracs)
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 23 Jan 2014 (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 investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). Since different regions of retina receive different radiation doses, the investigators will assess for a dose response as well.
Detailed description
Radiation therapy (RT) is a common treatment for patients with cancers of the sinonasal area, orbit, skull base, nasopharynx, and brain. Because of the close proximity of these targets to the eyes, the retina is often incidentally and unavoidably irradiated. As a result, some patients develop radiation retinopathy and possibly vision loss. Clinicopathologic studies suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small vessel occlusion and ischemia that can lead to neovascularization, increased capillary permeability, and visual loss in the regions of retina perfused by damaged vasculature. UNC has a novel, non-invasive retinal imaging technology called a Retinal Oximeter which measures hemoglobin oxygen saturation of retinal vessels. The difference in oxygen saturation between a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region supplied by that vessel pair.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a history of radiation therapy for a tumor in the vicinity of the retina(s) at the Department of Radiation Oncology, UNC-CH.
Key inclusion criteria (3 listed)
- ≥ 18 years of age at the time of radiation therapy (no upper age limit)
- History of radiation therapy delivered at UNC-CH or Rex Hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment
- Estimated average dose to at least one quadrant of one retina ≥ 30 Gy
Key exclusion criteria (2 listed)
- History of diabetes, retinal vascular occlusions, glaucoma, retinitis pigmentosa, occipital stroke or any other ophthalmologic or systemic problem that may confound visual field results.
- Residual tumor within the visual pathway: retina, optic nerves, optic chiasm, optic radiations and brain.
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
Abnormalities in regional retinal oxygen extraction after incidental irradiation of the retina.
Time frame: 2 months
To identify abnormalities in regional retinal oxygen extraction in patients who have had previous incidental irradiation of the retina.
Prevalence of vision loss in patients with previous incidental irradiation of the retina
Time frame: 2 months
To determine the prevalence of regional retinal dysfunction (i.e. vision loss) in patients with previous incidental irradiation of the retina.
3 secondary outcomes
Changes in retinal oxygen extraction compared to radiation dose
Time frame: 2 months
Vision loss amount versus radiation dose.
Time frame: 2 months
Changes in retinal oxygen extraction as compared to vision loss.
Time frame: 2 months
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 28 Aug 2019.
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.
Bhishamjit Chera, MD principal investigator
Department of Radiation Oncology, University of North Carolina Chapel Hill
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 A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s), run by UNC Lineberger Comprehensive Cancer Center 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 3 inclusion and 2 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 28 Aug 2019. 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?
Abnormalities in regional retinal oxygen extraction after incidental irradiation of the retina. (time frame: 2 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 28 Aug 2019.