Primary objective1. Assess that FAF can visualize the irradiated retina effects at an early stage after Ru-106 brachytherapy and PBT. Secondary objective1. Assess if these FAF-images can be correlated to the treatment plan.2. Correlate the observed…
ID
Source
Brief title
Condition
- Ocular neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
For Ru-106 brachytherapy and PBT treated patients between each timepoint:
Primary objective:
• Location of FAF changes
• Characteristic FAF changes (mottling pattern and rim of increased FAF).
Secondary outcome
Secondary objectives:
• For brachytherapy, the diameter of the FAF changes compared to the dimensions
of the used applicator.
• For PBT, distances of retina with FAF changes to the clip locations.
• Relation of FAF changes to abnormalities seen on OCT and funduscopic imaging
both at the same timepoint and at later timepoints.
Background summary
Uveal melanoma (UM) is the most common primary malignant intra-ocular tumour in
adults. Eye preserving treatments such as Ru-106 brachytherapy and proton beam
therapy are offered to the majority of patients. After treatment, a reduction
in tumour thickness on ultrasound is the primary indicator of treatment
response, but it can take up to a year to become apparent. Although both
treatments have a high, >95%, rate of local control, the treatment also induces
damage to the healthy retina surrounding the tumour, which threatens the
patient*s vision. A recent study showed that Fundus Autofluorescence (FAF) can
accurately visualize this radiation-induced damage within 6 months after
brachytherapy. We hypothesize that FAF could be a valuable instrument to
further improve the treatment, as it provides a means to directly link the
planned target volume to the actually treated volume. This recent
proof-of-principle study was however limited, as it only included brachytherapy
patients and did not include data on the treatment planning or other imaging
data post treatment.
Study objective
Primary objective
1. Assess that FAF can visualize the irradiated retina effects at an early
stage after Ru-106 brachytherapy and PBT.
Secondary objective
1. Assess if these FAF-images can be correlated to the treatment plan.
2. Correlate the observed changes on FAF-imaging with conventional ophthalmic
imaging (fundoscopy and OCT).
Study design
This study is a single centre prospective study design. All participants will
undergo optical imaging examinations before, 3- and 6 months after either
Ru-106 brachytherapy or proton beam therapy.
The patients will receive additional imaging exams consisting of: fundoscopic
imaging, FAF and Optical Coherence Tomography (OCT).
Study burden and risks
This study has no invasive procedures. Participants have no direct personal
benefit from participating in this study. However, the study results may
contribute to the improved treatment planning and/or follow-up of future
brachytherapy and proton beam therapy treated UM patients.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of primary uveal melanoma
- No history of previous uveal melanoma treatments
- No diagnosis of other retinal diseases
- Uveal melanoma patients who will be treated with either brachytherapy or
proton beam therapy
Exclusion criteria
- Subjects who are not legally capable
- Subjects under the age of 18
Design
Recruitment
Medical products/devices used
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 | NL86790.058.24 |