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

Not Applicable

Active, not recruiting

• Conditions: Hereditary Retinoblastoma
• Interventions: Procedure: MRI

• Registration Number: NCT03026998
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-03-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2034-03
• Study Completion: 2034-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Measure of sensibility of MRI to detect second primary cancer	Up to 10 years
Assess the visual prognosis of patients with second primary cancer depicted by MRI	Up to 10 year	Measure of residual visual functions before and after local treatment of the second primary cancer in patients depicted by MRI compared to that patients who the second primary cancer was depicted by clinical symptoms.
Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI	Up to 10 years
Collection of secondary tumors for future research purpose.	up to 10 years
Assess the feasibility of the MR screening program.	Up to 10 years	Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study.
Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.	Up to 10 years	- Quality of life questionnaires completed by the patient every year (before MRI) during 10 years.
Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.	Up to 10 years
Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI	Up to 10 years
Measure of specificity of MRI to detect second primary cancer	Up to 10 years
Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program	Up to 10 years

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France