RetinoblastomaNCT03439397
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
A study testing Ballon Technique and SOAI in people with Retinoblastoma and IAC, run by Guangzhou Women and Children's Medical Center.
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… Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Retinoblastoma, IAC, Selective Ophthalmic Artery Infusion
- What is being tested?
- Ballon Technique and SOAI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Being tested
- Ballon Technique, SOAI
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballon TechniqueDevice
Ballon Technique
SOAIDevice
SOAI
| Study group | Role | What they receive |
|---|---|---|
| Ballon Technique group | Experimental | Intervention：Ballon Technique Receives: Device: Ballon Technique |
| SOAI group | Active comparator | Intervention：Selective Ophthalmic Artery Infusion Receives: Device: SOAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three years from intervention
Secondary outcomes (2)
Visual pathway function
Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging
Measured: Three years from intervention
complications
Short and long term complications
Measured: Three years from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing zhang, Guangzhou Women and Children's Medical Center
- Investigators
- huiming xia, Study director, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439397
- Sponsor's protocol ID
- GZWACMC20180112
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
- ClinicalTrials.gov ID
- NCT03439397
- Acronym / sponsor ID
- GZWACMC20180112
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ballon Technique group | Experimental | Device: Ballon TechniqueIntervention：Ballon Technique |
| SOAI group | Active comparator | Device: SOAIIntervention：Selective Ophthalmic Artery Infusion |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballon TechniqueBallon Technique | Device | Ballon Technique group |
| SOAISOAI | Device | SOAI group |
Primary outcome
Globe salvage rate (Eyes saved/Eyes treated)
Time frame: Three years from intervention
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
2 secondary outcomes
Visual pathway function
Time frame: Three years from intervention
complications
Time frame: Three years from intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huiming xia study director
Guangzhou Women and Children's Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ballon Technique and SOAI in people with Retinoblastoma and IAC, run by Guangzhou Women and Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jing zhang (136262828465, fejr@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Globe salvage rate (Eyes saved/Eyes treated) (time frame: Three years from intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.