RBAPP: Smartphone App for Retinoblastoma

Brief Summary

Retinoblastoma is a rare, aggressive cancer in the developing retinas of infants and children. A common presenting sign of retinoblastoma is leukocoria, a white or lightly-colored reflection seen when a light is shown onto the eye’s pupil. Leukocoria may also indicate other diseases, including congenital cataracts.

Early diagnosis of retinoblastoma and other pediatric ophthalmologic diseases is crucial to improving treatment outcomes. The American Academy of Pediatrics recommends screening for these diseases via the red-reflex test with the ophthalmoscope, which may lack sensitivity and inter-user reliability and requires a degree of patient cooperation. 

This two-part study will compare a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) to the traditional red-reflex testing via direct ophthalmoscope. Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within patients known to have leukocoria. Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using the techniques selected from information gathered in Part 1), as compared to an ophthalmoscope, within patients referred to the clinic for suspected leukocoria.

Primary Objectives

• To determine the most effective usage of a camera phone application (CRADLE) to maximize detection of leukocoria in patients with retinoblastoma, congenital cataracts and glaucoma
• To estimate the sensitivity and specificity of a camera phone application in detecting leukocoria

Eligibility Criteria

Inclusion criteria include:

• 7 years old or younger
• Stratum I
  • Diagnosis of congenital or infantile cataracts and has not received prior therapy OR
  • Diagnosis of congenital glaucoma and has not received prior therapy OR
  • Newly diagnosed retinoblastoma or has received 2 cycles or less of chemoreductive therapy and has not undergone enucleation OR
  • Normal eyes
• Stratum II
  • No prior diagnosis but has been referred for ophthalmological evaluation, including for leukocoria or other conditions
• Stratum III
  • Diagnosis of retinoblastoma, undergoing ocular salvage treatment and completed second month of cytoreductive therapy

Exclusion Criteria include:

• Prior treatment for cataracts or glaucoma

Study Sites

St. Jude Children's Research Hospital
Memphis, Tennessee

About this study

Leukocoria is an eye condition that affects some children. Leukocoria means “white pupil.” It is the most common warning sign of retinoblastoma, a rare and serious childhood cancer of the eye. It can also be a sign of other diseases, including cataracts, glaucoma, retinal detachments and eye infections.

Currently, pediatricians and other doctors use a special tool to screen for leukocoria. This tool is called an ophthalmoscope. It allows the doctor to inspect the retina and other parts of the eye.  Unfortunately, not all doctors perform this screening regularly. Even when they do screen, the ophthalmoscope may not detect retinoblastoma tumors in the eye.  

In this study, researchers want to find out if a new method called CRADLE (ComputeR Assisted Detection of LEukocoria) will be better than the ophthalmoscope method at detecting leukocoria. CRADLE is a camera phone application that can be downloaded onto any smartphone device.

Purpose of this clinical trial

The main purpose of this study is to find out the best way to use the CRADLE app to identify leukocoria in children with retinoblastoma, congenital cataracts and glaucoma. Researchers hope to learn information that could help improve screening in the future, leading to earlier diagnosis of these conditions.

Eligibility overview

• 7 years old or younger
• Part I
  • Diagnosed with retinoblastoma and has not received any treatment OR
  • Diagnosed with cataracts and has not received any treatment OR
  • Diagnosed with glaucoma and has not received any treatment
• Part II
  • Referred to an eye doctor to check for leukocoria or other eye conditions
• Part III
  • Diagnosed with retinoblastoma and is receiving treatment