Retinoblastoma Consolidation in Egyptians

NCT07530458 | Not Yet Recruiting

• 1 other identifier: Retinoblastoma
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• Percentage of Globe salvage for treatment with Brachytherapy

  The number of eyes that were not enucleated due to the success of brachytherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with brachytherapy.

  Baseline

• Percentage of Globe salvage for treatment with cryotherapy

  The number of eyes that were not enucleated due to the success of cryotherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with cryotherapy.

  Baseline

• Percentage of Globe salvage for treatment with transpupillary thermotherapy

  The number of eyes that were not enucleated due to the success of transpupillary thermotherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with transpupillary thermotherapy.

  Baseline

Interventions

Cryotherapy PROCEDURE

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.

Brachytherapy RADIATION

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.

transpupillary thermotherapy PROCEDURE

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.

Also known as: TTT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of Patients with RB who received Ru-106 plaque brachytherapy, cryotherapy, and/or TTT as salvage treatment after systemic intravenous chemotherapy (IVC) from October 2019 to April 2026

You may qualify if:

• Patients receiving secondary consolidation therapy with at least one year of post-treatment follow-up.

You may not qualify if:

• Incomplete data, extraocular or orbital RB at initial presentation, or follow-up duration under one year.

Sponsors & Collaborators

• Assiut University: lead

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MeSH Terms

Conditions

Retinoblastoma

Interventions

Cryotherapy; Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy

Study Officials

• Tamer Macky, PhD

  Cairo University

  STUDY DIRECTOR

• Abdussalam Abdussalam, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amr Sayed, Msc

CONTACT

+201096083988; amr_mohamed_sayed3@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04