Back to resultsRCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Primary Purpose
Retinoblastoma, IAC, Selective Ophthalmic Artery Infusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ballon Technique
SOAI
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ballon Technique group
SOAI group
Arm Description
Intervention：Ballon Technique
Intervention：Selective Ophthalmic Artery Infusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual pathway function
Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging
complications
Short and long term complications
Full Information
NCT ID
NCT03439397
First Posted
January 29, 2018
Last Updated
February 28, 2018
Sponsor
Guangzhou Women and Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03439397
Brief Title
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Official Title
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma, IAC, Selective Ophthalmic Artery Infusion, Ballon Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
496 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ballon Technique group
Arm Type
Experimental
Arm Description
Intervention：Ballon Technique
Arm Title
SOAI group
Arm Type
Active Comparator
Arm Description
Intervention：Selective Ophthalmic Artery Infusion
Intervention Type
Device
Intervention Name(s)
Ballon Technique
Intervention Description
Ballon Technique
Intervention Type
Device
Intervention Name(s)
SOAI
Intervention Description
SOAI
Primary Outcome Measure Information:
Title
Globe salvage rate (Eyes saved/Eyes treated)
Description
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
Time Frame
Three years from intervention
Secondary Outcome Measure Information:
Title
Visual pathway function
Description
Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging
Time Frame
Three years from intervention
Title
complications
Description
Short and long term complications
Time Frame
Three years from intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jing zhang
Phone
136262828465
Email
fejr@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
huiming xia
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
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