RetinoblastomaNCT05028270
Treatment of Intraocular Retinoblastoma
An observational study of Retinoblastoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Balloon technology;Microcatheter technology
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 1 Aug 2023
- Phase
- Observational
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children dignosed retinoblastoma
Who may be able to join
- 1 year old <age ≤ 18 years old;
- After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
- Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
- ECOG scale (ECOG-PS) ≤ 2;
Who cannot join
- No antibiotics and no gastrointestinal surgery within 3 months.
- Patients with autoimmune diseases;
- Patients with immunodeficiency;
- Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;
- Multiple organ failure;
- Uncontrolled infection and diarrhea
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma
This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma
Read the detailed description
Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.
- Conditions
- Retinoblastoma
- Being tested
- Balloon technology;Microcatheter technology
- Keywords
- Retinoblastoma;Intravenous chemotherapy;Eye protection rate
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon technology;Microcatheter technologyProcedure or surgery
Describe each group's intervention in sufficient detail, including how and when to give the intervention Suspend or modify the criteria for interventions that have been assigned to the subject (such as changing the dose of the drug due to hazards or subject requirements or improvement/deterioration of the condition, etc.) Strategies to improve the compliance of intervention programs, and other measures to monitor compliance (such as the return of drug tablets, laboratory inspections, etc.) Related care and interventions allowed or prohibited during the trial
| Study group | Role | What they receive |
|---|---|---|
| Balloon technology | The femoral artery is introduced after the patient is fully anesthetized. First, the 5F-VETERBRAL is introduced under the guidance of the guidance. The common carotid artery and internal carotid artery will be received laterally. After whole-body heparinization, micro-catheter and guide wire technology are used. In the figure below, the proximal end of the 4mm super-form occlusion ball is marked far away from the eye, plugged and sealed, and the guide tube is pushed around in the internal carotid artery. When the occlusion is finished, the internal carotid artery and the ophthalmic artery are not accompanied far away, and the plot is good. The guiding catheter drives the injection of drugs, topotecar, and topotecan for 5 minutes (the suction balloon is opened and blocked, and the infusion is continuous) to complete the infusion. Receives: Procedure: Balloon technology;Microcatheter technology | |
| Microcatheter technology | The tip of the Marathon microcatheter is placed at the opening of the ophthalmic artery. After the contrast agent is confirmed by hand, the chemotherapeutic drugs The femoral artery is introduced after the patient is fully anesthetized. First, the 5F-VETERBRAL is introduced under the guidance of the guidance. Maphalan, carboplatin, and topotecan are injected sequentially for 30 minutes. Make sure that the tip position of the catheter is not maintained during the injection process. verb: move. After the operation is completed, the blocking balloon is pulled out under the guidance of the guide wire, the arterial sheath is removed, and the femoral artery puncture point is pressed to stop bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
To evaluate the 1-year ocular salvage rate in the treatment of retinoblastoma [ Time Frame: 1 year ] 12-month ocular salvage rate: calculate the number and percentage of subjects who reach 12-month ocular salvage rate, and use the exact probability method to estimate 95% CI.
Measured: 1 year
Second tumor rate
To evaluate the 1-year recurrence of the tumor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start20 Jun 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Aug 2023 (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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Shi, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028270
- Sponsor's protocol ID
- XH-21-06
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma
- ClinicalTrials.gov ID
- NCT05028270
- Acronym / sponsor ID
- XH-21-06
- Conditions
- Retinoblastoma
- Keywords
- Retinoblastoma;Intravenous chemotherapy;Eye protection rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 31 Aug 2021 (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.
This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma
Detailed description
Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon technology | – | Procedure: Balloon technology;Microcatheter technologyThe femoral artery is introduced after the patient is fully anesthetized. First, the 5F-VETERBRAL is introduced under the guidance of the guidance. The common carotid artery and internal carotid artery will be received laterally. After whole-body heparinization, micro-catheter and guide wire technology are used. In the figure below, the proximal end of the 4mm super-form occlusion ball is marked far away from the eye, plugged and sealed, and the guide tube is pushed around in the internal carotid artery. When the occlusion is finished, the internal carotid artery and the ophthalmic artery are not accompanied far away, and the plot is good. The guiding catheter drives the injection of drugs, topotecar, and topotecan for 5 minutes (the suction balloon is opened and blocked, and the infusion is continuous) to complete the infusion. |
| Microcatheter technology | – | –The tip of the Marathon microcatheter is placed at the opening of the ophthalmic artery. After the contrast agent is confirmed by hand, the chemotherapeutic drugs The femoral artery is introduced after the patient is fully anesthetized. First, the 5F-VETERBRAL is introduced under the guidance of the guidance. Maphalan, carboplatin, and topotecan are injected sequentially for 30 minutes. Make sure that the tip position of the catheter is not maintained during the injection process. verb: move. After the operation is completed, the blocking balloon is pulled out under the guidance of the guide wire, the arterial sheath is removed, and the femoral artery puncture point is pressed to stop bleeding. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children dignosed retinoblastoma
Key inclusion criteria (4 listed)
- 1 year old <age ≤ 18 years old;
- After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
- Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
- ECOG scale (ECOG-PS) ≤ 2;
Key exclusion criteria (6 listed)
- No antibiotics and no gastrointestinal surgery within 3 months.
- Patients with autoimmune diseases;
- Patients with immunodeficiency;
- Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;
- Multiple organ failure;
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 |
|---|---|---|
| Balloon technology;Microcatheter technologyDescribe each group's intervention in sufficient detail, including how and when to give the intervention Suspend or modify the criteria for interventions that have been assigned to the subject (such as changing the dose of the drug due to hazards or subject requirements or improvement/deterioration of the condition, etc.) Strategies to improve the compliance of intervention programs, and other measures to monitor compliance (such as the return of drug tablets, laboratory inspections, etc.) Related care and interventions allowed or prohibited during the trial | Procedure or surgery | Balloon technology |
Primary outcome
Overall success rate
Time frame: 1 year
To evaluate the 1-year ocular salvage rate in the treatment of retinoblastoma [ Time Frame: 1 year ] 12-month ocular salvage rate: calculate the number and percentage of subjects who reach 12-month ocular salvage rate, and use the exact probability method to estimate 95% CI.
Second tumor rate
Time frame: 1 year
To evaluate the 1-year recurrence of the tumor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
Min Shi study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 4 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 Jun 2022. 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 Chaohui Jin, Phd, MD (+8613636694571, 13636694571@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall success rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Jun 2022.