RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

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Brief Title

RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

Official Title

RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

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.
    


Study Type

Interventional


Primary Outcome

Globe salvage rate (Eyes saved/Eyes treated)

Secondary Outcome

 Visual pathway function

Condition

Retinoblastoma

Intervention

Ballon Technique

Study Arms / Comparison Groups

 Ballon Technique group
Description:  Intervention:Ballon Technique

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

496

Start Date

March 2018

Completion Date

December 2020

Primary Completion Date

December 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

1 Month - 10 Years

Accepts Healthy Volunteers

No

Contacts

huiming xia, 136262828465, [email protected]



Administrative Informations


NCT ID

NCT03439397

Organization ID

GZWACMC20180112


Responsible Party

Principal Investigator

Study Sponsor

Guangzhou Women and Children's Medical Center


Study Sponsor

huiming xia, Study Director, Guangzhou Women and Children's Medical Center


Verification Date

February 2018