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

Hereditary Retinoblastoma Clinical Trial

— DepiSCARRH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03026998
• Other study ID #: IC 2015-14 DepISCARRH
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 19, 2017
• Est. completion date: March 2034

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: March 2034
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

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

Related Conditions & MeSH terms

• Hereditary Retinoblastoma
• Neoplasms, Second Primary
• Retinoblastoma

Intervention

Procedure:
• MRI
MRI will be performed each year during 10 years.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	Up to 10 years
Secondary	Assess the visual prognosis of patients with second primary cancer depicted by MRI	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.	Up to 10 year
Secondary	Assess the feasibility of the MR screening program.	Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study.	Up to 10 years
Secondary	Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program		Up to 10 years
Secondary	Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.	- Quality of life questionnaires completed by the patient every year (before MRI) during 10 years.	Up to 10 years
Secondary	Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.		Up to 10 years
Secondary	Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI		Up to 10 years
Secondary	Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI		Up to 10 years
Secondary	Measure of sensibility of MRI to detect second primary cancer		Up to 10 years
Secondary	Measure of specificity of MRI to detect second primary cancer		Up to 10 years
Secondary	Collection of secondary tumors for future research purpose.		up to 10 years