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SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

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ClinicalTrials.gov Identifier: NCT02329002
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
ODAS
Information provided by (Responsible Party):
Marcus de Jong, VU University Medical Center

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.


Condition or disease Intervention/treatment
Retinoblastoma Device: Magnetic resonance imaging

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: 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.


Primary Outcome Measures :
  1. Diagnostic accuracy of MRI for the detection of second primary tumors in hereditary irradiated retinoblastoma [ Time Frame: 4 years ]
    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).


Secondary Outcome Measures :
  1. 5-year survival [ Time Frame: 9 years ]
    A secondary objective is to assess the 5-year survival of second primary tumors (SPT) found by screening, SPTs missed by screening, and the non-SPT patients

  2. Descriptive statistics [ Time Frame: 4 years ]
    Recording and monitoring location and characteristics (clinical, radiological, histological, treatment) of patients with SPTs: total number of patients included, median follow-up time + range, number of asymptomatic SPTs detected by screening, number of symptomatic SPTs missed by screening, number of SPTs developed after the end of screening, number of SPTs that were totally resected, location of tumor, type of tumor, size of tumor

  3. Feasability assessment [ Time Frame: 4 years ]
    Assessment of the feasibility of such this screening program: (a) percentage of patients (or family) willing to participate; (b) compliance of patients and their families to the screening program

  4. Assessing the psychosocial burden or benefit [ Time Frame: 4 years ]
    Once a year during the visits, the patient will be asked to fill out the Hospital Anxiety and Depression Scale (HADS).



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329002


Contacts
Contact: Marcus C de Jong, MD, MSc +31204440814 mc.dejong@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Marcus C de Jong, MC, MSc    +31204440814    mc.dejong@vumc.nl   
Sponsors and Collaborators
VU University Medical Center
ODAS
Investigators
Study Chair: Jonas A Castelijns, PhD VU University Medical Center

Responsible Party: Marcus de Jong, Mr., VU University Medical Center
ClinicalTrials.gov Identifier: NCT02329002     History of Changes
Other Study ID Numbers: Rb-SPT-SCR
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Marcus de Jong, VU University Medical Center:
Retinoblastoma
Second primary tumor
Screening
Magnetic resonance imaging

Additional relevant MeSH terms:
Retinoblastoma
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
Retinal Diseases