Ballon Technique, IAC, Retinoblastoma, Selective Ophthalmic Artery Infusion
Conditions
Brief summary
Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon technique , another is selective ophthalmic artery infusion.This study evaluates the difference of Ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. Half of participants will receive, Ballon technique while the other half will receive selective ophthalmic artery infusion
Detailed description
Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Two alternative means can be used,The purpose of this study is to show that Ballon technique and SOAI delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.
Interventions
DEVICEBallon Technique
Ballon Technique
DEVICESOAI
SOAI
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
1. No age limit, no gender limit, monocular or binocular affected; 2. New diagnosed cases, without any previous treatment; 3. Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated; 4. Normal bone marrow function 5. Normal liver function 6. Normal kidney function 7. Normal coagulation function 8. To be willing to take part in the clinical trial and sign the informed consent form; 9. To be willing to have these tumor sites surgically removed and do the follow up accordingly.
Exclusion criteria
1. Diagnosis is not clear; 2. With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization); 3. With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia; 4. Took part in other clinical study within 3 months; 5. Refuse to take part in this clinical study; 6. Is not willing to do the follow up accordingly or follow up less than 2 times.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Globe salvage rate (Eyes saved/Eyes treated) | Three years from intervention | Event defined as the need for external beam enucleation，To assess the saving of eyes affected with IAC for patients who would have been candidates for enucleation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual pathway function | Three years from intervention | Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging |
| complications | Three years from intervention | Short and long term complications |
Contacts
Primary Contactjing zhang
Outcome results
None listed