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

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

Study Overview

• Status: Unknown
• Conditions: Retinoblastoma; IAC; Selective Ophthalmic Artery Infusion; Ballon Technique
• Intervention / Treatment: Device: Ballon Technique; Device: SOAI

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
• Enrollment (Anticipated): 496
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; SOAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Globe salvage rate (Eyes saved/Eyes treated)	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	Three years from intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual pathway function	Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging	Three years from intervention
complications	Short and long term complications	Three years from intervention

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Study Director: huiming xia, Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Eye Diseases; Retinal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Eye Diseases, Hereditary; Eye Neoplasms; Retinal Neoplasms; Retinoblastoma
• Other Study ID Numbers: GZWACMC20180112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No