NCT03267459

Brief Summary

Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97% of 5-years survival rate. Conservative treatments are being more and more used, and intra arterial chemotherapy is one of the adjuvant treatments proposed to the children. The treatment is efficient in most cases, but a small proportion of children will have an early progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for early identification of children response to intra arterial chemotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
51mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2018Jul 2030

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

10 years

First QC Date

August 28, 2017

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • response to chemotherapy

    Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy.

    18 months

Interventions

Dynamic contrast-enhanced perfusion sequences added to MRI examination performed at the beginning of intra arterial chemotherapy.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with retinoblastoma, undergoing intra arterial chemotherapy

You may qualify if:

  • grade B to D retinoblastoma
  • prescription of intra arterial chemotherapy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A De Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Augustin Lecler, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Salomon, MD PhD

CONTACT

Augustin Lecler, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

January 11, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations