Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma? (PREDIR)

July 10, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Prediction of the Response Using Dynamic Contrast-enhanced Magnetic Resonance Imaging Before Intra-arterial Chemotherapy in Children With Retinoblastoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75019
        • Recruiting
        • Fondation A De Rothschild
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient with retinoblastoma, undergoing intra arterial chemotherapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response to chemotherapy
Time Frame: 18 months
Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Augustin Lecler, MD, Fondation OPH A de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALR_2017_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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