Status:
UNKNOWN
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Lead Sponsor:
Guangzhou Women and Children's Medical Center
Conditions:
Retinoblastoma
IAC
Eligibility:
All Genders
1-10 years
Phase:
NA
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 ophthal...
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 ...
Eligibility Criteria
Inclusion
- No age limit, no gender limit, monocular or binocular affected;
- New diagnosed cases, without any previous treatment;
- Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated;
- Normal bone marrow function
- Normal liver function
- Normal kidney function
- Normal coagulation function
- 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
- Diagnosis is not clear;
- With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization);
- With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia;
- Took part in other clinical study within 3 months;
- Refuse to take part in this clinical study;
- Is not willing to do the follow up accordingly or follow up less than 2 times.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT03439397
Start Date
March 1 2018
End Date
December 1 2020
Last Update
March 1 2018
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