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NCT03267459 Clinical Trial

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

Retinoblastoma Clinical Trial

— PREDIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03267459
Other study ID # ALR_2017_2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 11, 2018
Est. completion date July 2026

Study information
Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Laurence Salomon, MD PhD
Phone 0148036431
Email lsalomon@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - grade B to D retinoblastoma - prescription of intra arterial chemotherapy Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Fondation A De Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary response to chemotherapy Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy. 18 months
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