Treatment of Intraocular Retinoblastoma

Study Purpose

This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 1 year old Exclusion Criteria: 1. No antibiotics and no gastrointestinal surgery within 3 months. 2. Patients with autoimmune diseases; 3. Patients with immunodeficiency; 4. 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; 5. Multiple organ failure; 6. Uncontrolled infection and diarrhea

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05028270
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Min Shi
Principal Investigator Affiliation Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Retinoblastoma
Additional Details

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.

Arms & Interventions

Arms

: 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

Procedure: - Balloon technology;Microcatheter technology

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chaohui Jin, Phd, MD

13636694571@163.com

+8613636694571

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Stay Informed & Connected