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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03267459
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 101.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Device: Dynamic contrast-enhanced MRI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prediction of the Response Using Dynamic Contrast-enhanced Magnetic Resonance Imaging Before Intra-arterial Chemotherapy in Children With Retinoblastoma
• Actual Study Start Date: Jan 11, 2018
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jul 1, 2026

Outcome Measures

Primary Outcome Measures

1. response to chemotherapy [18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• grade B to D retinoblastoma

• prescription of intra arterial chemotherapy

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation A De Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03267459
• Other Study ID Numbers: ALR_2017_2
• First Posted: Aug 30, 2017
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinoblastoma

Study Results

No Results Posted as of Mar 21, 2022