Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

NCT03016156 | Terminated

• 2 other identifiers: RBAPPNCI-2021-05557
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine whether a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria. There will be no impact on participants' health outcome. This study will be performed in two parts, each with a distinct cohort of patients. 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 (CRADLE) in detecting leukocoria.

Conditions

Retinoblastoma; Cataracts Infantile; Glaucoma, Congenital; Leucocoria

Outcome Measures

Primary Outcomes (3)

• Rate of detection of leukocoria using CRADLE

  This outcome will assess the feasibility of various techniques and conditions for using CRADLE in participants with retinoblastoma, congenital cataracts, and glaucoma. The most effective usage of CRADLE to maximize detection of leukocoria will be determined by review of all images, and the most effective and efficient technique will be selected based on the findings and the clarity of the images. This technique will be used for completion of the subsequent objectives using a new cohort of participants.

  Day 1

• Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria

  The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of true positive. An ideal test for sensitivity has no false positives.

  Up to Day 4

• Specificity of CRADLE versus ophthalmoscope to detect leukocoria

  The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of false negatives (specificity). An ideal test for sensitivity has no false negatives.

  Up to Day 4

Study Arms (3)

Stratum I: Initial Evaluation Group

EXPERIMENTAL

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.

Other: CRADLE

Stratum II: Leukocoria Evaluation Group

EXPERIMENTAL

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.

Other: CRADLE; Other: Red reflex testing

Stratum III: Retinoblastoma Group

EXPERIMENTAL

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.

Other: CRADLE; Other: Red reflex testing

Interventions

CRADLE OTHER

A smartphone software application designed to detect leukocoria using a sophisticated photoluminic analysis. The investigator or designee will perform tests with CRADLE in separate patient cohorts with known diagnosis of retinoblastoma, congenital glaucoma, or cataracts.

Also known as: Smartphone application, ComputeR Assisted Detection of LEukocoria

Stratum I: Initial Evaluation Group; Stratum II: Leukocoria Evaluation Group; Stratum III: Retinoblastoma Group

Red reflex testing OTHER

Traditional red reflex testing for leukocoria using a direct ophthalmoscope on routine eye examination. Red reflex testing via direct ophthalmoscope will be performed before dilation, using the ophthalmoscope held close to the examiner's eye, focused on the pupil, viewed at 12 to 18 inches from the patient's eyes, with the room lights dimmed, in accordance with the American Academy of Pediatrics guidelines.

Also known as: Ophthalmoscopic exam

Stratum II: Leukocoria Evaluation Group; Stratum III: Retinoblastoma Group

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient has been diagnosed with congenital or infantile cataracts, congenital glaucoma, or retinoblastoma, and is scheduled for a visit with an ophthalmologist at St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute.
• Patient with retinoblastoma is newly diagnosed, or has received \< 2 cycles of chemoreductive therapy, and has not undergone enucleation.
• Patient with cataracts or glaucoma has not received any prior therapy.
• Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions.
• Patient with retinoblastoma undergoing ocular salvage treatment.

You may not qualify if:

• Prior treatment for cataracts or glaucoma
• Inability or unwillingness of research participant or legal guardian to consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Retinoblastoma; Hydrophthalmos

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; Eye Abnormalities; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Carlos Rodriguez-Galindo, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 10, 2017
• Study Start: March 15, 2018
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)