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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06367569
Other study ID # 2012//375
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2012
Est. completion date September 1, 2023

Study information

Verified date April 2024
Source Amsterdam UMC, location VUmc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (<15 mm) are potentially curable. Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts. Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma. Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients. Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Screening for trilateral retinoblastoma with MRI
The diagnostic accuracy of the screening program, baseline screening with MRI followed by follow-up of suspicious pineal glands in heritable retinoblastoma patients.

Locations

Country Name City State
Netherlands VU University Medical Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of the screening The sensitivity and specificity of the baseline screening and extended follow-up will be determined 01-10-2012
Secondary Survival analysis of trilateral retinoblastoma patients Analysis of (overall) survival after trilateral retinoblastoma 01-10-2012
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