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

NCT03439397 | Unknown

• 1 other identifier: GZWACMC20180112
• Study Type: interventional
• Target: 496
• Locations: 0 countries
• Sites: N/A

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

Conditions

Retinoblastoma; IAC; Selective Ophthalmic Artery Infusion; Ballon Technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual pathway function

  Three years from intervention

• complications

  Three years from intervention

Study Arms (2)

Ballon Technique group

EXPERIMENTAL

Intervention：Ballon Technique

Device: Ballon Technique

SOAI group

ACTIVE COMPARATOR

Intervention：Selective Ophthalmic Artery Infusion

Device: SOAI

Interventions

Ballon Technique DEVICE

Ballon Technique

Ballon Technique group

SOAI DEVICE

SOAI

SOAI group

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• huiming xia

  Guangzhou Women and Children's Medical Center

  STUDY DIRECTOR

Central Study Contacts

jing zhang

CONTACT

136262828465; fejr@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jing Zhang, Head of Department of Interventional Radiology

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 20, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share