Clinical Trials in France / NCT03026998
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Curie | Paris | France |
More Institut Curie trials in 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