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

Retinoblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03439397
• Other study ID #: GZWACMC20180112
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 28, 2018
• Start date: March 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2018
• Source: Guangzhou Women and Children's Medical Center
• Contact: jing zhang
• Phone: 136262828465
• Email: fejr[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 496
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ballon Technique
• IAC
• Retinoblastoma
• Selective Ophthalmic Artery Infusion

Intervention

Device:
• Ballon Technique
Ballon Technique
• SOAI
SOAI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	complications	Short and long term complications	Three years from intervention