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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03439397
Recruitment Status : Not yet recruiting
First Posted : February 20, 2018
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Jing zhang, Guangzhou Women and Children's Medical Center

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

Condition or disease Intervention/treatment Phase
Retinoblastoma IAC Selective Ophthalmic Artery Infusion Ballon Technique Device: Ballon Technique Device: SOAI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ballon Technique group
Intervention:Ballon Technique
Device: Ballon Technique
Ballon Technique

Active Comparator: SOAI group
Intervention:Selective Ophthalmic Artery Infusion
Device: SOAI

Primary Outcome Measures :
  1. Globe salvage rate (Eyes saved/Eyes treated) [ Time Frame: 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 Outcome Measures :
  1. Visual pathway function [ Time Frame: 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

  2. complications [ Time Frame: Three years from intervention ]
    Short and long term complications

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03439397

Contact: jing zhang 136262828465

Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Study Director: huiming xia Guangzhou Women and Children's Medical Center

Responsible Party: Jing zhang, Jing Zhang, Head of Department of Interventional Radiology, Guangzhou Women and Children's Medical Center Identifier: NCT03439397     History of Changes
Other Study ID Numbers: GZWACMC20180112
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases