Treatment of Intraocular Retinoblastoma
Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma
1 other identifier
observational
1,600
0 countries
N/A
Brief Summary
This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJune 1, 2022
June 1, 2021
3 months
August 25, 2021
May 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
1 year
Second tumor rate
To evaluate the 1-year recurrence of the tumor.
1 year
Study Arms (2)
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.
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.
Interventions
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
Eligibility Criteria
Children dignosed retinoblastoma
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Min Shi
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 31, 2021
Study Start
June 20, 2022
Primary Completion
October 1, 2022
Study Completion
August 1, 2023
Last Updated
June 1, 2022
Record last verified: 2021-06