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

NCT ID: NCT03439397

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2020-12-31

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.

Conditions

Retinoblastoma; IAC; Selective Ophthalmic Artery Infusion; Ballon Technique

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ballon Technique group

Intervention：Ballon Technique

Group Type: EXPERIMENTAL

Ballon Technique

Intervention Type: DEVICE

Ballon Technique

SOAI group

Intervention：Selective Ophthalmic Artery Infusion

Group Type: ACTIVE_COMPARATOR

SOAI

Intervention Type: DEVICE

SOAI

Interventions

Ballon Technique

Ballon Technique

Intervention Type: DEVICE

SOAI

SOAI

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jing zhang

Jing Zhang, Head of Department of Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

huiming xia

Role: STUDY_DIRECTOR

Guangzhou Women and Children's Medical Center

Central Contacts

jing zhang

Role: CONTACT

fejr@foxmail.com

136262828465

Other Identifiers

GZWACMC20180112

Identifier Type: -

Identifier Source: org_study_id