Retinoblastoma Consolidation in Egyptians

April 8, 2026 updated by: Amr Mohamed Sayed, Assiut University

Retinoblastoma Consolidation: A Retrospective Multivariate Analysis In Egyptian Population

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

As the most prevalent pediatric eye malignancy, retinoblastoma (RB) represents roughly 11% of cancers identified during an infant's first year, with the vast majority (95%) being diagnosed by age five. While medical priorities in developed nations have transitioned from merely saving the eye to actively preserving vision, clinical reality differs elsewhere; over 90% of children with RB live in developing or underdeveloped regions, where the disease often remains undetected until it has reached advanced stages that jeopardize the eye.

(RB) is managed through a diverse range of therapeutic strategies, including systemic chemotherapy (IVC), intra-arterial (IAC) and intravitreal (IViC) approaches, cryotherapy, laser-based treatments, plaque radiotherapy, and surgical enucleation. Each of these methods presents a unique profile of clinical advantages and potential complications. Currently, systemic IVC is the most common frontline treatment, frequently used in tandem with consolidating focal therapies such as laser therapy, cryotherapy, or Plaque Brachytherapy.

Plaque brachytherapy remains a vital tool for treating thicker tumors that are not suitable for laser or cryotherapy. It is particularly prioritized in salvage scenarios where preserving the eye is critical, such as when the patient's other eye has already been enucleated.

A significant clinical benefit of plaque therapy is its localized nature; unlike external beam radiation therapy (EBRT), it does not elevate the risk of secondary malignancies in the patient. Whether utilized as an initial treatment or as a rescue measure following IVC or IAC, focal plaque radiotherapy has demonstrated eye salvage success rates between 55% and 79% for new or recurrent focal tumors.

Ruthenium-106 (Ru-106) plaque radiotherapy has a long-standing history as both a primary intervention and a rescue therapy for tumors that fail to regress or recur after chemoreduction with a wide range of prescribed apex doses and treatment results. Research indicates that using isotopes like Ruthenium-106 and Iodine-125 results in impressive local tumor control (60%-90%) and high globe preservation rates.

To the best of the investigators' knowledge, no previous research analysis has been done on the outcomes of consolidation therapy using Ru-106, laser, or cryotherapy for retinoblastoma in the Egyptian population.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Globe salvage for treatment with Brachytherapy
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Tamer Macky, PhD, Cairo university
  • Study Director: Abdussalam Abdussalam, PhD, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retinoblastoma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinoblastoma

Clinical Trials on transpupillary thermotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe