MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by Exter… (NCT03026998) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)
France88 participantsStarted 2017-03-19
Plain-language 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).
Who can participate
Age range7 Years
SexALL
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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
What they're measuring
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).