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

Learn more about:
Related Clinical Trial
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma RB Liquid Biopsy Biorepository Topotecan and Melphalan for Retinoblastoma Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure – Preliminary Study Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma. Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study Topotecan Episcleral Plaque for Treatment of Retinoblastoma G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment PCI Imaging System in Pediatric Ophthalmology Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients Conservative Treatments of Retinoblastoma Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma Photoscreening for Retinoblastoma RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients Studying Health Outcomes After Treatment in Patients With Retinoblastoma Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma Phase I Trial of Periocular Topotecan in Retinoblastoma Episcleral Topotecan for Treatment of Group D Retinoblastoma Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma? CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation Alternating Systemic Chemotherapy and Intra-Arterial Melphalan (IAM) Chemotherapy in Children With Intra-Ocular Retinoblastoma Chemotherapy in Treating Patients With Retinoblastoma New Strategies to Detect Cancers in Carriers of Mutations in RB1 Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma Carboplatin Plus Vincristine in Treating Children With Retinoblastoma Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma Quality of Life in Children Cured of Retinoblastoma Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009) Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma SPT Screening in Irradiated Hereditary Retinoblastoma Survivors Attention to Retinoblastoma Diagnosed in the Trauma Setting Carboplatin Periocular Injection for Retinoblastoma Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala Research on the Environment and Children’s Health: Retinoblastoma Intravitreal Injections of Melphalan for Retinoblastoma Efficacy Study of Lucentis in the Treatment of Retinoblastoma Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life Retinoblastoma Biomarker Study Cancer Biology of Retinoblastoma Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma Intra-arterial Chemotherapy for Children With Retinoblastoma Molecular Analysis of Retinoblastoma

Brief Title

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

Official Title

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

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.
    

Detailed Description

      This study will utilize three strata called Stratum I, Stratum II and Stratum III.

      STRATUM I - Infants and children known to have leukocoria who have been diagnosed with
      retinoblastoma, cataracts or glaucoma or other eye conditions.

      Participants enrolled on Stratum I of the study will have the CRADLE application used by the
      doctor during their appointment.

      The participant will look straight forward while the doctor stands about 1-3 feet away
      holding the device that has the CRADLE application. He or she will slowly move the device up,
      down, middle, right, and left - both in a lit and dimmed room.

      The participant will be videotaped and photographed during this appointment. The doctor will
      record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or
      positive for leukocoria).

      STRATUM II - Infants and children who are referred to an eye doctor to evaluate for
      leukocoria.

      Participants enrolled on Stratum II of the study will be asked to look straight forward while
      he or she uses the CRADLE application (using the best method determined from Stratum I). The
      doctor will also examine the participant's eyes with the ophthalmoscope method. The results
      from both CRADLE and the ophthalmoscope method will be recorded and compared (white eye
      present versus absent, and normal versus abnormal as described above).

      STRATUM III - Infants and children receiving treatment for retinoblastoma. For participants
      enrolled on Stratum III, he or she will have the same procedures as described in Stratum II.

      After receiving informed consent, participants will undergo evaluation by ophthalmoscope and
      CRADLE on Day 1. Stratum III participants only will also undergo CRADLE evaluation on Days 2,
      3, and 4.
    


Study Type

Interventional


Primary Outcome

Rate of detection of leukocoria using CRADLE


Condition

Retinoblastoma

Intervention

CRADLE

Study Arms / Comparison Groups

 Stratum I: Initial Evaluation Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

290

Start Date

March 15, 2018

Completion Date

June 30, 2023

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria - Stratum I:

          -  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.

        Inclusion Criteria - Stratum II:

          -  Patient without prior diagnosis has been referred for ophthalmological evaluation,
             including leukocoria or other conditions.

        Inclusion Criteria - Stratum III:

          -  Patient with retinoblastoma undergoing ocular salvage treatment.

        Exclusion Criteria

          -  Prior treatment for cataracts or glaucoma

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

Gender

All

Ages

N/A - 7 Years

Accepts Healthy Volunteers

No

Contacts

Carlos Rodriguez-Galindo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03016156

Organization ID

RBAPP


Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital


Study Sponsor

Carlos Rodriguez-Galindo, MD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

April 2021