SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

NCT02329002 | Unknown

• 1 other identifier: Rb-SPT-SCR
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Hereditary retinoblastoma survivors have an increased risk to develop second primary tumors (SPT) at a later age (with the highest risk in their teens), especially when they have been irradiated for retinoblastoma. The investigators hypothesize that regular screening with magnetic resonance imaging (MRI) could lead to early detection of SPTs leading to improved survival. Objective: To evaluate the potential benefit of craniofacial MRI screening for early detection subclinical secondary cancers in patients previously irradiated for hereditary retinoblastoma. Study design: Prospective multicenter non-invasive screening study. The total study duration will be four years of screening plus five years of follow-up. Study population: Irradiated hereditary retinoblastoma patients 8-18 years old Main study parameters/endpoints: To evaluate the ability of craniofacial MRI for early detection of SPTs, the investigators will determine the sensitivity and specificity of MRI at detecting SPTs in irradiated hereditary retinoblastoma patients. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients will undergo yearly craniofacial MRI for a period of 4 years. They will also be asked to fill out a psychological burden assessment form each visit. A potential risk of screening might be associated anticipatory anxiety, but screening also could be reassuring for patients and their parents; the investigators are not sure which will outweigh. False-positive results from MRI screening could lead to unnecessary further diagnostics leading to possible added anxiety and diagnostics (e.g., biopsies). However, this group of patients have a high risk of developing SPTs, with poor 5-year survival statistics. Early detection and therefore treatment of earlier stage (smaller) tumors, might therefore increase survival of this patient group.

Conditions

Retinoblastoma

Keywords

Retinoblastoma; Second primary tumor; Screening; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of MRI for the detection of second primary tumors in hereditary irradiated retinoblastoma

  The primary objective of the study is to evaluate the benefit of early detection of craniofacial second primary tumors with MRI in previously irradiated hereditary retinoblastoma survivors. The main outcome measure for assessing the benefit of screening will be the diagnostic accuracy of MRI for detecting craniofacial SPTs: sensitivity (true-positive and false-negative results) and specificity (true-negative and false-positive results).

  4 years

Secondary Outcomes (4)

• 5-year survival

  9 years

• Descriptive statistics

  4 years

• Feasability assessment

  4 years

• Assessing the psychosocial burden or benefit

  4 years

Interventions

Magnetic resonance imaging DEVICE

MR imaging protocol should include a thin-slice (3-4 mm) short TI inversion recovery (STIR) sequence or fat-saturated T2-weighted images in axial direction. Furthermore, a 3D-T1 weighted sequence with isotropic voxels will be obtained, with reconstruction in 3 directions. If suspicious lesions are detected, additional MR imaging has to be performed, including contrast-enhanced images.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The potential study population will be irradiated hereditary retinoblastoma survivors in the Netherlands and joining centers from other countries. Currently, there is no screening program for these high-risk patients. The age of patients at highest risk of developing craniofacial SPTs is 8-18 years.

You may qualify if:

• Patients with a history of hereditary retinoblastoma
• Patients that have been treated with external beam radiotherapy for retinoblastoma
• Age of patients at the first MR scan: 8 years or older (≥8 years old), but only as soon as the MR scan can be performed without sedation or general anesthesia, and until and including 18 years of age (≤18 years old).

You may not qualify if:

• Claustrophobia
• Foreign non MR compatible metal objects in the body
• Foreign incompatible metal objects in or close to the head

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ODAS: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jonas A Castelijns, PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

Central Study Contacts

Marcus C de Jong, MD, MSc

CONTACT

+31204440814; mc.dejong@vumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 31, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2023
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

NL (1)