MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)

NCT03026998 | Active Not Recruiting

• 1 other identifier: IC 2015-14
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the benefit of MR screening for asymptomatic head \& neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).

Conditions

Hereditary Retinoblastoma

Keywords

hereditary retinoblastoma,; External beam radiation therapy (EBRT)

Outcome Measures

Primary Outcomes (1)

• Assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).

  Rate of patients with R0-resection quality (versus R1 or R2) among patients with second primary cancer depicted by MRI, with comparison to historical series

  Up to 10 years

Secondary Outcomes (10)

• Assess the visual prognosis of patients with second primary cancer depicted by MRI

  Up to 10 year

• Assess the feasibility of the MR screening program.

  Up to 10 years

• Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program

  Up to 10 years

• Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.

  Up to 10 years

• Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.

  Up to 10 years

Study Arms (1)

MRI

OTHER

Procedure: MRI

Interventions

MRI PROCEDURE

MRI will be performed each year during 10 years.

MRI

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Personal history of hereditary retinoblastoma (i.e., familial history of retinoblastoma, or bilateral retinoblastoma, or unilateral multifocal retinoblastoma, or identified germline RB1 mutation or 13q deletion)
• External beam radiation therapy (EBRT) used for retinoblastoma treatment
• Written informed consent signed by patient (or legal representative)

You may not qualify if:

• Personal history of non-familial unilateral unifocal retinoblastoma without RB1 germline mutation.
• Personal history of second primary neoplasm occurring within radiation fields
• Contraindication for MRI (pacemaker, intraocular metallic foreign body, defibrillators or other implanted electronic devices, intracranial ferro-magnetic clips) or associated conditions preventing from MR examination (intraocular prostheses and implants are not a contraindication for MRI; orthodontic metallic devices are not a contraindication but might decrease the image quality and should be removed, if possible)
• Patients unable to comply with follow-up study requirements, for any geographical, social or psychological reason

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Hervé BRISSE, MD

  NSTITUT CURIE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 20, 2017
• Study Start: March 19, 2017
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)