SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    VU University Medical Center
Updated on 8 November 2020
anesthesia
cancer

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.

Details
Condition Retinoblastoma
Treatment magnetic resonance imaging
Clinical Study IdentifierNCT02329002
SponsorVU University Medical Center
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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

MRI related 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
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