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Retinoblastoma Consolidation in Egyptians

NCT07530458 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-04-15

No results posted yet for this study

Summary

This analysis will evaluate the investigators' institution's specific experience using Ru-106 isotopes, cryotherapy, or transpupillary thermotherapy (TTT) to treat persistent or recurrent RB in patients who previously underwent systemic IVC or IAC. The investigators aim to detail the demographics, clinical indications, success rates-specifically local control and globe salvage-, predictive factors for success, and complications of each modality of treatment within a tertiary eye care setting in Egypt.

Conditions

  • Retinoblastoma

Interventions

PROCEDURE

transpupillary thermotherapy

The 810 nm red laser (Iridex Oculight SLx) is used via an indirect delivery system for transpupillary applications under general anesthesia. The goal is a gentle white spot at the tumor-retina boundary. Technique: Placement: Begin at the lesion edge, placing burns half-on and half-off the tumor. Titration: Increase power/duration until a reaction is seen. Punctate hemorrhage warns of maximum power density. Coverage: Create a perimeter with overlapping burns, then treat the entire lesion. Central thick areas may not whiten. Parameters: Set duration to 9000 milliseconds (ms) and interval to 50 ms for foot-pedal control (continuous mode). This allows for photocoagulation (1-10s) or thermotherapy (30-60s). Primary (Peripheral/Macular): Start at 300 milliwatt (mW). Chemoreduction (Large Tumors): Start at 400-500 mW; can increase to 800 mW with careful monitoring if no reaction occurs.

PROCEDURE

Cryotherapy

The ERBE Erbokryo AE system is utilized to treat peripheral lesions. Before use, the probe must be tested for proper ice ball formation. Technique: Localization: Position the probe tip using indirect ophthalmoscopy and scleral indentation. Freezing: Center the tip under the tumor. The ice ball must extend 1-2 mm beyond the tumor apex to encompass potential vitreous seeds. Monitoring: Control the lateral spread to minimize damage to healthy retina. Cycles: Apply double or triple freeze-thaw cycles for maximum efficacy. Precautions: Limit treatment to 2-3 sites per session to reduce the risk of secondary serous or rhegmatogenous retinal detachment.

RADIATION

Brachytherapy

Plaque insertion is performed under general anesthesia. Precise tumor localization is achieved through simultaneous indirect ophthalmoscopy and transillumination; the tumor projection is marked on the sclera using blue ink. Muscles may be temporarily detached for proper seating. Planning and Dosimetry:Equipment: Ru-106 plaques (e.g., BEBIG) are used for tumors up to 7 mm thick and 17 mm in diameter.Dose: Following American Brachytherapy Society (ABS) guidelines, 90 gray (Gy) is delivered at 0.6-1.05 Gy/hr over 3-7 days.Margins: Calculation includes tumor height + 1 mm sclera. A 2-3 mm lateral margin and a 1 mm safety margin are maintained. Vitreous Seeds: Add 1 mm to the thickness calculation if local seeds are present.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Tamer Macky, PhD · Cairo University

  • Abdussalam Abdussalam, PhD · Cairo University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530458 on ClinicalTrials.gov