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Active, not recruiting Not applicable

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

NCT03026998 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2017-03-19
Last updated
2025-09-15

Condition(s) studied

Hereditary Retinoblastoma

Investigational drug(s) / intervention(s)

MRI

MRI: MRI will be performed each year during 10 years.

Study 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).

Eligibility

Sex
ALL
Min age
7 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * Age at inclusion greater or equal to 7 years old. * Time period between the end of EBRT and inclusion date of 5 years or more * Written informed consent signed by patient (or legal representative) Exclusion Criteria: * 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

Primary outcome measure(s)

  • 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). — Up to 10 years
    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

Trial sites (1)

FacilityCityRegionStatus
Institut Curie Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03026998 on ClinicalTrials.gov ↗ ← All trials in France