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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2015-002948-14-HU |
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Date of registration:
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24/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A new PET radiopharmaceutical in Hungary to detect brain tumors
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Scientific title:
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Application of a new radioligand F-18 FET, and its clinical benefit in the diagnosis of primary and secondary brain tumors - - |
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Date of first enrolment:
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22/09/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002948-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: MRI
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Innovation Director
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Address:
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Thököly u. 12.
2120
Dunakeszi
Hungary |
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Telephone:
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36303974378 |
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Email:
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iherenyik@expintuitive-innovation.com |
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Affiliation:
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PET Diagnosztikai Kft. |
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Name:
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Innovation Director
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Address:
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Thököly u. 12.
2120
Dunakeszi
Hungary |
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Telephone:
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36303974378 |
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Email:
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iherenyik@expintuitive-innovation.com |
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Affiliation:
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PET Diagnosztikai Kft. |
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Key inclusion & exclusion criteria
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Inclusion criteria:
histologically confirmed primary or secondary brain tumor
previous MRI study (T1WI, PDWI, T2WI, postcontrast T1WI)
clinical history is available
cooperating patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Exclusion criteria:
non-cooperating patient
clinical data are not available
claustrophobia
patient refused participation
pregnancy or breast feeding
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
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Primary and secondary brain tumors
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Intervention(s)
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Product Name: FET-PET oldatos injekció
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Main Objective: Clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI
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Secondary Objective: Quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for assessing prognosis
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Primary end point(s): Accessing the clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI.
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Timepoint(s) of evaluation of this end point: Evaluation of this endpoint Dec. 20, 2016
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Evaluation of this endpoint Dec. 20, 2016
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Secondary end point(s): Testing the applicability of quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for estimating prognosis
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Source(s) of Monetary Support
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R&D Project GOP-1.3.1-11/A-2011-0136
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Ethics review
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Status: Approved
Approval date: 07/09/2015
Contact:
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