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).
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Full eligibility criteria for NCT03026998
Ages eligible for Study
7 Years to 35 Years
Genders eligible for Study
Accepts Healthy Volunteers
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 between 7 and 35 years
Time period between the end of EBRT and inclusion date of 5 years or more
Written informed consent signed by patient (or legal representative)
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
All locations for NCT03026998
Paris, France, 75005
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View full eligibility
Tris trial is registered with FDA with number: NCT03026998. The sponsor of the trial is Institut Curie and it is looking for 190 volunteers for the current phase.
Official trial title: MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma
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