AzTrials
AzTrials

RetinoblastomaNCT07530458

Retinoblastoma Consolidation in Egyptians

An observational study of Retinoblastoma, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Retinoblastoma
What is being tested?
transpupillary thermotherapy, Cryotherapy and Brachytherapy
Type of treatment
Surgery or procedure
How many people
150 participants
Where
No sites listed yet
Study dates
1 May 2026to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Amr Sayed, Msc contact

+201096083988

amr_mohamed_sayed3@yahoo.com

About this study

Official title: 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.

Read the 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.

Conditions
Retinoblastoma
Being tested
transpupillary thermotherapy, Cryotherapy, Brachytherapy
Medical subject headings
Retinoblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transpupillary thermotherapyProcedure or surgery

    Also called TTT

    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.

  • CryotherapyProcedure or surgery

    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.

  • BrachytherapyRadiation

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07530458
Sponsor's protocol ID
Retinoblastoma
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
15 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Broaddus E, Topham A, Singh AD. Incidence of retinoblastoma in the USA: 1975-2004. Br J Ophthalmol. 2009 Jan;93(1):21-3. doi: 10.1136/bjo.2008.138750. Epub 2008 Jul 11.

    PubMed 18621794

  • Rodriguez-Galindo C, Wilson MW, Chantada G, Fu L, Qaddoumi I, Antoneli C, Leal-Leal C, Sharma T, Barnoya M, Epelman S, Pizzarello L, Kane JR, Barfield R, Merchant TE, Robison LL, Murphree AL, Chevez-Barrios P, Dyer MA, O'Brien J, Ribeiro RC, Hungerford J, Helveston EM, Haik BG, Wilimas J. Retinoblastoma: one world, one vision. Pediatrics. 2008 Sep;122(3):e763-70. doi: 10.1542/peds.2008-0518.

    PubMed 18762512

  • Shields CL, Say EAT, Pefkianaki M, Regillo CD, Caywood EH, Jabbour PM, Shields JA. RHEGMATOGENOUS RETINAL DETACHMENT AFTER INTRAARTERIAL CHEMOTHERAPY FOR RETINOBLASTOMA: The 2016 Founders Award Lecture. Retina. 2017 Aug;37(8):1441-1450. doi: 10.1097/IAE.0000000000001382.

    PubMed 27787452

  • Shields CL, Dockery PW, Yaghy A, Duffner ER, Levin HJ, Taylor OS, Sajjadi Z, Lally SE, Shields JA, Rosenwasser R, Tjoumakaris S, Jabbour P. Intra-arterial chemotherapy for retinoblastoma in 341 consecutive eyes (1,292 infusions): comparative analysis of outcomes based on patient age, race, and sex. J AAPOS. 2021 Jun;25(3):150.e1-150.e9. doi: 10.1016/j.jaapos.2020.12.006. Epub 2021 May 24.

    PubMed 34044113

  • Kaliki S, Vempuluru VS, Mohamed A, Al-Jadiry MF, Bowman R, Chawla B, Hamid SA, Ji X, Kapelushnik N, Kebudi R, Sthapit PR, Rojanaporn D, Sitorus RS, Yousef YA, Fabian ID; Global Retinoblastoma Study Group. Retinoblastoma in Asia: Clinical Presentation and Treatment Outcomes in 2112 Patients from 33 Countries. Ophthalmology. 2024 Apr;131(4):468-477. doi: 10.1016/j.ophtha.2023.10.015. Epub 2023 Oct 13.

    PubMed 37839559

  • Tomar AS, Finger PT, Gallie B, Kivela TT, Mallipatna A, Zhang C, Zhao J, Wilson MW, Brenna RC, Burges M, Kim J, Khetan V, Ganesan S, Yarovoy A, Yarovaya V, Kotova E, Yousef YA, Nummi K, Ushakova TL, Yugay OV, Polyakov VG, Ramirez-Ortiz MA, Esparza-Aguiar E, Chantada G, Schaiquevich P, Fandino A, Yam JC, Lau WW, Lam CP, Sharwood P, Moorthy S, Long QB, Essuman VA, Renner LA, Semenova E, Catala J, Correa-Llano G, Carreras E; American Joint Committee on Cancer Ophthalmic Oncology Task Force. Global Retinoblastoma Treatment Outcomes: Association with National Income Level. Ophthalmology. 2021 May;128(5):740-753. doi: 10.1016/j.ophtha.2020.09.032. Epub 2020 Sep 29.

    PubMed 33007338

  • Hiasat JG, Saleh A, Al-Hussaini M, Al Nawaiseh I, Mehyar M, Qandeel M, Mohammad M, Deebajah R, Sultan I, Jaradat I, Mansour A, Yousef YA. The predictive value of magnetic resonance imaging of retinoblastoma for the likelihood of high-risk pathologic features. Eur J Ophthalmol. 2019 Mar;29(2):262-268. doi: 10.1177/1120672118781200. Epub 2018 Jun 11.

    PubMed 29890860

  • Schaiquevich P, Francis JH, Cancela MB, Carcaboso AM, Chantada GL, Abramson DH. Treatment of Retinoblastoma: What Is the Latest and What Is the Future. Front Oncol. 2022 Apr 1;12:822330. doi: 10.3389/fonc.2022.822330. eCollection 2022.

    PubMed 35433448

  • Yousef YA, Al-Nawaiseh I, Mehyar M, Sultan I, Al-Hussaini M, Jaradat I, Mohammad M, AlJabari R, Abu-Yaghi N, Rodriguez-Galindo C, Qaddoumi I, Wilson M. How Telemedicine and Centralized Care Changed the Natural History of Retinoblastoma in a Developing Country: Analysis of 478 Patients. Ophthalmology. 2021 Jan;128(1):130-137. doi: 10.1016/j.ophtha.2020.07.026. Epub 2020 Jul 16.

    PubMed 32682835

  • Yousef YA, Hajja Y, Nawaiseh I, Mehyar M, Sultan I, Deebajah R, Rawashdeh K, Khurma S, Jaradat I, Al-Hussaini M. A histopathologic analysis of 50 eyes primarily enucleated for retinoblastoma in a tertiary cancer center in Jordan. Turk Patoloji Derg. 2014;30(3):171-7. doi: 10.5146/tjpath.2014.01260.

    PubMed 24913302

  • Servodidio CA, Abramson DH. Acute and long-term effects of radiation therapy to the eye in children. Cancer Nurs. 1993 Oct;16(5):371-81.

    PubMed 8261386

  • Abramson DH, Ellsworth RM, Rozakis GW. Cryotherapy for retinoblastoma. Arch Ophthalmol. 1982 Aug;100(8):1253-6. doi: 10.1001/archopht.1982.01030040231003.

    PubMed 7103809

  • Shields CL, Mashayekhi A, Sun H, Uysal Y, Friere J, Komarnicky L, Shields JA. Iodine 125 plaque radiotherapy as salvage treatment for retinoblastoma recurrence after chemoreduction in 84 tumors. Ophthalmology. 2006 Nov;113(11):2087-92. doi: 10.1016/j.ophtha.2006.04.032. Epub 2006 Sep 1.

    PubMed 16949158

  • Shields CL, Shields JA, Cater J, Othmane I, Singh AD, Micaily B. Plaque radiotherapy for retinoblastoma: long-term tumor control and treatment complications in 208 tumors. Ophthalmology. 2001 Nov;108(11):2116-21. doi: 10.1016/s0161-6420(01)00797-7.

    PubMed 11713089

  • Palkonda VAR, Ramachandran A, Adewara BA, Verma R, Raval V, Kaliki S. Ruthenium-106 (106Ru) plaque brachytherapy as salvage treatment for retinoblastoma following intravenous chemotherapy. Brachytherapy. 2025 Jan-Feb;24(1):76-85. doi: 10.1016/j.brachy.2024.06.008. Epub 2024 Nov 22.

    PubMed 39580311

Questions about this trial

What is this clinical trial studying?

An observational study of Retinoblastoma, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amr Sayed, Msc (+201096083988, amr_mohamed_sayed3@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Globe salvage for treatment with Brachytherapy (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07530458, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in