Clinical trial NCT03026998: MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)
Official title: MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hereditary Retinoblastoma
Keywords: hereditary retinoblastoma,
External beam radiation therapy (EBRT)
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 88
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Detailed description: Patients with hereditary retinoblastoma treated during infancy by external beam radiation therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high. The aim of this study is to depict by MRI secondary tumors as early as possible, before the occurrence of clinical symptoms. Affected patients will be further managed in a national expert center with dedicated diagnostic and treatment procedures. However, the benefit of such management has to be assessed in terms of prognosis.

Eligibility criteria: 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 outcomes:
measure: 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).
timeFrame: Up to 10 years
Secondary outcomes:
measure: Assess the visual prognosis of patients with second primary cancer depicted by MRI
timeFrame: Up to 10 year
measure: Assess the feasibility of the MR screening program.
timeFrame: Up to 10 years
measure: Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program
timeFrame: Up to 10 years
measure: Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.
timeFrame: Up to 10 years
measure: Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
timeFrame: Up to 10 years
measure: Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
timeFrame: Up to 10 years
measure: Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
timeFrame: Up to 10 years
measure: Measure of sensibility of MRI to detect second primary cancer
timeFrame: Up to 10 years
measure: Measure of specificity of MRI to detect second primary cancer
timeFrame: Up to 10 years
measure: Collection of secondary tumors for future research purpose.
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: NSTITUT CURIE
name: Hervé BRISSE, MD
role: PRINCIPAL_INVESTIGATOR
References: