SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retinoblastoma

Keywords

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Retinoblastoma Second primary tumor Screening Magnetic resonance imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetic resonance imaging

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Claustrophobia
* Foreign non MR compatible metal objects in the body
* Foreign incompatible metal objects in or close to the head
* Exclusion criterium for additional contrast sequences: Allergic reaction to contrast administration in the past

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Marcus de Jong

Mr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonas A Castelijns, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marcus C de Jong, MD, MSc

Role: CONTACT

Phone: +31204440814

Email: [email protected]

Facility Contacts

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Marcus C de Jong, MC, MSc

Role: primary

Other Identifiers

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Rb-SPT-SCR

Identifier Type: -

Identifier Source: org_study_id