1. Assess the effect of Ru-106 brachytherapy applicators on tumor dimensions. 2. Assess the value of DWI and PWI as an early predictor of therapy response after Ru-106 brachytherapy in UM.
ID
Source
Brief title
Condition
- Ocular neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Tumor dimensions: Prominence, largest basal diameter, second basal diameter.
2. Changes in tumor dimensions, volume between the different time points.
3. Tumor apparent diffusion coefficient (ADC), time-intensity curve (TIC),
pharmacokinetic parameters (Ktrans, Ve, Vp).
Secondary outcome
Additional changes in the radiological appearance of the UM on MRI, such as:
• Signal on T1 and T2 (measured relative to the choroid and eye muscle
respectively)
• Homogeneity of the lesion
• Presence of retinal detachment
• Localization compared to FAF
Background summary
Brachytherapy is the optimal treatment modality for small to medium sized uveal
melanoma (UM), which is the most common primary malignant intra-ocular tumor in
adults. Conventionally, 2D Ultrasound (US) is used to plan the brachytherapy,
e.g. the tumor height determines the treatment duration, and for follow-up,
e.g. a decrease in tumor height. In recent years, we have introduced MR-Imaging
as a new and valuable imaging modality for UM, as it can provide 3D volumetric
and functional data of the tumor, which can potentially improve the therapy
planning and follow-up.
Currently, the time during which the brachytherapy applicator is attached to
the eye, is based on the pretreatment tumor height. It is, however, not known
if the suturing of the applicator results in a deformation of the eye and or
tumor, which could result in an over- or underdosage of the tumor. Moreover,
functional MRI techniques, such as diffusion weighted imaging (DWI) and
perfusion weighted imaging (PWI), have been proposed as an early marker of
therapy response, but have not been systematically evaluated.
Study objective
1. Assess the effect of Ru-106 brachytherapy applicators on tumor dimensions.
2. Assess the value of DWI and PWI as an early predictor of therapy response
after Ru-106 brachytherapy in UM.
Study design
The study is a single-center prospective study. All participants will undergo
an MRI scan before, during and 3 and 6 months after Ru-106 brachytherapy.
The patients will receive 3Tesla MRI scans using a dedicated UM protocol which
is also used clinically for patients who receive proton beam therapy. The
protocol contains anatomical scans, used to assess the tumor dimensions, and
functional scans. The MRI data will be compared to the conventional ophthalmic
imaging data, in particular Ultrasound imaging, as well as, Fundus
Autofluorescence (FAF).
Study burden and risks
This study has no invasive procedures. Subjects with contraindications for MRI
will be excluded. There are no known risks associated with MRI and the presence
of brachytherapy applicators in-situ. 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 brachytherapy
in future UM patients.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of primary UM
2. UM lesions arising from the choroid or ciliary body
3. No history of previous UM treatments
4. UM patients who will be treated with brachytherapy
5. Tumor prominence >3 mm
Exclusion criteria
1. Subjects who are not legally capable
2. Subjects under the age of 18
3. Contraindications to MRI scanning, including:
o Claustrophobia
o Pregnancy
o Pacemakers and defibrillators
o Nerve stimulators
o Intracranial clips
o Metallic fragments
o Cochlear implants
o Ferromagnetic implants
o Hydrocephalus pump
o Permanent make-up
o Tattoos above the shoulders
o Subjects who cannot keep their head still (eg. Tremor, Parkinson*s disease)
o Severe physical restriction (eg. completely wheelchair dependent)
o In the case of uncertainty about the MRI-contraindications, the MR-safety
commission of the radiology department will
decide whether this subject can be included in the study or not.
4. Contra indication for gadolinium such as renal insufficiency or contrast
allergy
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 | NL81227.058.22 |