What is the mechanism of action of this treatment?

Common treatments for retinoblastoma include chemotherapy, radiation therapy, laser therapy, cryotherapy, and enucleation. Chemotherapy uses drugs to kill cancer cells or stop them from dividing. Radiation therapy uses high-energy rays to target and destroy cancer cells. Laser therapy (photocoagulation) uses focused light to destroy blood vessels that supply the tumor. Cryotherapy involves freezing cancer cells to kill them. Enucleation is the surgical removal of the eye when the tumor is too large to be treated by other means. Early detection of retinoblastoma, as facilitated by the CRADLE smartphone application, is crucial because it allows for timely intervention with these treatments, potentially preserving vision and improving survival rates.

What side effects are associated with this type of intervention?

Common treatments for retinoblastoma include chemotherapy, radiation therapy, and enucleation. Chemotherapy can cause nausea, vomiting, hair loss, and increased infection risk. Radiation therapy may lead to skin irritation, fatigue, growth abnormalities, and secondary cancers. Enucleation results in the loss of vision in the affected eye and may have psychological impacts.

What prior FDA approvals exist?

The FDA has approved several treatments for retinoblastoma, which is a rare eye cancer that typically affects young children. Traditional treatments include chemotherapy, radiation therapy, laser therapy, cryotherapy, and enucleation (surgical removal of the eye). More recently, intra-arterial chemotherapy, where drugs are delivered directly to the eye, and intravitreal chemotherapy, where drugs are injected into the eye, have been used to treat retinoblastoma. While the CRADLE application is a diagnostic tool designed to detect leukocoria, which can be an early sign of retinoblastoma, it does not directly relate to treatment. However, early detection through tools like CRADLE can significantly improve treatment outcomes by identifying the disease at an earlier, more treatable stage.

What other types of research exist?

Promising alternatives to CRADLE for detecting leukocoria in retinoblastoma patients include advanced AI-based diagnostic tools and portable imaging devices. AI algorithms integrated with smartphone applications or standalone devices can enhance image analysis accuracy. Additionally, portable optical coherence tomography (OCT) devices and handheld fundus cameras offer high-resolution imaging capabilities, which can be crucial for early detection and monitoring of retinoblastoma.

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Smartphone App Detection for Retinoblastoma

N/A

Recruiting

Led By Carlos Rodriguez-Galindo, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stratum III: Patient with retinoblastoma undergoing ocular salvage treatment.

Be younger than 18 years old

Must not have

Prior treatment for cataracts or glaucoma

Inability or unwillingness of research participant or legal guardian to consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 4

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a smartphone app called CRADLE to help detect leukocoria in children. The app takes pictures of the eyes and looks for signs of this condition. It aims to improve early detection in kids who have or might have serious eye diseases.

Who is the study for?

This trial is for patients with retinoblastoma, congenital cataracts, or glaucoma who are visiting St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute. It includes new or minimally treated retinoblastoma cases and those referred for eye conditions like leukocoria.

What is being tested?

The study tests the CRADLE smartphone app's ability to detect leukocoria compared to traditional red reflex testing using an ophthalmoscope. The trial has two parts: finding the best way to use CRADLE and measuring its accuracy (sensitivity and specificity).

What are the potential side effects?

Since this study involves a diagnostic tool that does not impact health outcomes directly, there are no anticipated side effects from participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am receiving treatment to save my eye from retinoblastoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had treatment for cataracts or glaucoma.

Select...

I am unable or unwilling to give consent for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of detection of leukocoria using CRADLE

Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria

Specificity of CRADLE versus ophthalmoscope to detect leukocoria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum III: Retinoblastoma GroupExperimental Treatment2 Interventions

A separate group of participants with known retinoblastoma and who are undergoing ocular salvage treatments will be screened with red reflex testing using direct ophthalmoscopy on Day 1. They will also undergo testing with the CRADLE software application defined as the most effect in Stratum I on Day 1 then for three additional consecutive visits which typically occur every 3 to 4 weeks.

Group II: Stratum II: Leukocoria Evaluation GroupExperimental Treatment2 Interventions

A separate group of participants who are referred for evaluation of leukocoria or any other eye condition will undergo red reflex testing testing with CRADLE on Day 1.

Group III: Stratum I: Initial Evaluation GroupExperimental Treatment1 Intervention

Initially, a small group of patients diagnosed with congenital or infantile cataracts, congenital glaucoma or retinoblastoma and who meet the eligibility criteria will undergo testing with CRADLE on Day 1.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for retinoblastoma include chemotherapy, radiation therapy, laser therapy, cryotherapy, and enucleation. Chemotherapy uses drugs to kill cancer cells or stop them from dividing. Radiation therapy uses high-energy rays to target and destroy cancer cells. Laser therapy (photocoagulation) uses focused light to destroy blood vessels that supply the tumor. Cryotherapy involves freezing cancer cells to kill them. Enucleation is the surgical removal of the eye when the tumor is too large to be treated by other means. Early detection of retinoblastoma, as facilitated by the CRADLE smartphone application, is crucial because it allows for timely intervention with these treatments, potentially preserving vision and improving survival rates.

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