SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

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Brief Title

SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

Official Title

Multicenter Implementation of MR Imaging Studies in Irradiated Hereditary Retinoblastoma Survivors for Assessment of the Value of Craniofacial MRI Screening for Early Detection of Second Craniofacial Primary Tumors and to Enhance Survival

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.
    



Study Type

Observational


Primary Outcome

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

Secondary Outcome

 5-year survival

Condition

Retinoblastoma

Intervention

Magnetic resonance imaging


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

400

Start Date

October 2014

Completion Date

October 2023

Primary Completion Date

October 2018

Eligibility Criteria

        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
      

Gender

All

Ages

8 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Jonas A Castelijns, PhD, +31204440814, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02329002

Organization ID

Rb-SPT-SCR


Responsible Party

Principal Investigator

Study Sponsor

VU University Medical Center

Collaborators

 ODAS

Study Sponsor

Jonas A Castelijns, PhD, Study Chair, VU University Medical Center


Verification Date

December 2014