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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Carlos Rodriguez-Galindo, MD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2018-03-15
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 290
Treatments
Experimental: Stratum I: Initial Evaluation Group
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.
Experimental: Stratum II: Leukocoria Evaluation Group
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.
Experimental: Stratum III: Retinoblastoma Group
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.
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov