Clinical trial · Observational

Treatment of Intraocular Retinoblastoma

Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma

NCT05028270CI-TRIAL-00058848unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Retinoblastoma	Retinoblastoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Balloon technology;Microcatheter technology	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Balloon technology
description
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.
interventionNames
1. Procedure: Balloon technology;Microcatheter technology
label
Microcatheter technology
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year
Maximum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. 1 year old \<age ≤ 18 years old;
2. After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
3. Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
4. ECOG scale (ECOG-PS) ≤ 2;

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

References

Publications (0)

Data not yet available

No reference posted for this study.