To gain insight into the incidence of retinopathy and optic neuropathy in relation to the radiation dose in order to develop a normal tissue complication probability (NTCP) model for the eye and the optic tract.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
- Determine retinopathy and optic neuropathy and translate this to ocular
damage map
- Develop irradiation dosimetry map of the eye / optic tract
- Combine both maps to determine prediction model and NTCP
Secondary outcome
- possible other side effects of the eye and/or optic tract caused by
irradiation of malignancies arising in the brain, head and neck such as; dry
eye, cataract , and scleral necrosis.
- the impact on QoL of ocular complications caused by irradiation of the eye
and/or optic tract
- the influence of concurrent parameters such as hypertension, diabetes
mellitus, smoking (previous and history), alcohol intake, dyslipidemia, family
history of cardiovascular disease, personal history of cardiovascular disease,
cardiovascular risk estimation for the following 10-years (based on the
Framingham Coronary Heart Disease Risk Score) on the development of radiation
induced retinopathy and optic neuropathy
Background summary
Radiotherapy (RT) is a mainstay treatment for a variety of intracranial, head
and neck tumors such as; sinusoidal tumors, nasopharyngeal tumor, orbital
rhabdomyosarcoma and meningioma*s. Due to the complex anatomical relationship
it is inevitable to prevent irradiation of healthy tissues surrounding the
mentioned tumors. Irradiation of these tumors often involves the eye and optic
tract which can induce various ocular complications, including radiation
induced dry eye, cataract, secondary glaucoma from neovascularization of the
iris, scleral necrosis, retinopathy and optic neuropathy. Radiation retinopathy
and optic neuropathy are the two most visually significant complications of
radiotherapy. With the advent of new irradiation technologies such as;
Intensity Modulated Radiotherapy (IMRT), Volumetric Arc Therapy (VMAT), proton
therapy, and the Magnetic Resonance Linear accelerator (MR-Linac), precise dose
distributions conform the target are realizable. Considering this, it is likely
that irradiation of the eye and/or the optic tract can be lessened.
Furthermore, the dose-response relationship for irradiation of parts of the eye
and the optic tract is not well established so it is not known where and to
what extent to decrease the dose. Gaining more insight in to radiation induced
retinopathy and optic neuropathy is needed to develop a prediction model in
order to minimize irradiation of the optic tract while performing radiotherapy
for sinusoidal tumors, nasopharyngeal rhabdomyosarcoma or meningioma*s. With
the new possibilities of modern radiation techniques now more than ever correct
prediction of side effects are needed.
Study objective
To gain insight into the incidence of retinopathy and optic neuropathy in
relation to the radiation dose in order to develop a normal tissue complication
probability (NTCP) model for the eye and the optic tract.
Study design
Prospective multicenter self-controlled study design in which the eye and optic
tract of the not irradiated side is the control for the irradiated side.
Study burden and risks
Barring some minor discomfort to the subjects no severe risk is expected as a
result of this study. First, after administration of fluorescein 100mg/ml
solution patients can experience minor transitory complaints such as; vomiting,
nausea, dizziness, and headache. In rare cases minor allergic reactions can
occur including; itching of the skin, redness, and urticaria. In exceptional
cases (1 in 10 000) an anaphylactic reaction can occur. Second, mydriasis is
provided by topical mydriastic eye drops, including topical tropicamide 0.5%
and/or phenylephrine 5%. These drops can temporarily lead to local irritation
of the eyes or blurred vision. Therefore, patients are advised not to drive a
car during the first 4 hours after examination.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
the following criteria:
- >18 years of age
- Underwent external beam radiation therapy (EBRT) for sinusoidal tumors,
nasopharyngeal tumor, orbital rhabdomyosarcoma, uveal melanoma or meningioma
for >= 2 years
- Signed informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Any ocular disease / abnormality that prevents good quality imaging of the
retina.
- Any ocular disease / abnormality that presents asymmetrically (affecting one
eye more than the other e.g., anisometropia) that could influence the outcome
measurements and is not related to radiation.
- Other medical conditions which enables patients to participate the study e.g.
psychologically not able to participate or undergoing palliative treatment.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71040.058.20 |