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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004846
Receipt No. R000005769
Scientific Title Advanced neuroimaging protocol, including 3T MRI with triple-dose gadoteridol administration, for histopathological characterization of glioma and prediction of the patient's prognosis
Date of disclosure of the study information 2011/01/17
Last modified on 2012/08/09

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Basic information
Public title Advanced neuroimaging protocol, including 3T MRI with triple-dose gadoteridol administration, for histopathological characterization of glioma and prediction of the patient's prognosis
Acronym Advanced neuroimaging protocol, including MRI with triple-dose gadoteridol administration, for histopathological characterization of glioma
Scientific Title Advanced neuroimaging protocol, including 3T MRI with triple-dose gadoteridol administration, for histopathological characterization of glioma and prediction of the patient's prognosis
Scientific Title:Acronym Advanced neuroimaging protocol, including MRI with triple-dose gadoteridol administration, for histopathological characterization of glioma
Region
Japan

Condition
Condition Glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify whether all non-enhancing gliomas are really non-enhancing by MRI after intravenous administration of triple-dose contrast agent gadoteridol using clinical 3 T MRI, and to evaluate the predictive values of neuroimaging on histopathological characteristics of the tumor and progression-free survival of the patient.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Histopathological characteristics of glioma
Key secondary outcomes Progression free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 For non-enhancing glioma at the time of initial diagnosis,
1) Intravenous administration of single-dose gadoteridol (0.2 ml/kg body weight)
2) Acquisition of T1-weighted MR images within 10 minutes of contrast administration
3) Additional intravenous administration of double-dose gadoteridol (0.4 ml/kg body weight), which result in cumulative triple-dose of gadoteridol (0.6 ml/kg body weight)
4) Second acquisition of T1-weighted MR images within 10 minutes of contrast administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1)age of the patient from 20 to 65 years
(2)newly diagnosed intraaxial non-enhancing glioma
(3)agreement of the patient and his or her nearest family member for participation in the study and informed consent for neuroradiological investigation
(4)absence of contraindications for contrast-enhanced MRI and PET investigations, such as
-implanted heart pacemaker device
-intravascular stents (any location)
-intracranial vascular clips
-cochlear implants
-crystalline lens protheses
-other implanted ferromagnetic objects or magnetically/mechanically activated devices
(5)absence of the history of anaphylactoid reactions, respiratory difficulties, respiratory allergic disease, and adverse reactions to iodinated contrast media
(6)absence of pregnancy and lactation
(7)absence of diabetes mellitus and any decompensated chronic diseases
(8)normal renal function
-absence of positive risk factors for renal insufficiency (kidney disease, previous renal surgery, proteinuria, diabetes mellitus, arterial hypertension, gout)
-normal level of serum creatinine (men: 0.69-1.06 mg/dl, women: 0.48-0.79 mg/dl)
-estimated glomerular filtration rate >70ml/min/1.73m2
(9)initiation of the diagnostic work-up and treatment within the study period
Key exclusion criteria (1) presence of contrast enhancement on T1-weighted 1.5 T MRI after intravenous administration of single-dose (0.2 ml/kg) gadoteridol; these patients will be enrolled into full investigational protocol but their data will be analyzed separately;
(2) absence of surgical treatment in TWMU within 1 month after completion of the neuroradiological investigation;
(3) establishment of any histpathological diagnosis after resective surgery other than glioma of astrocytic, oligodendroglial, or ependymal origin, neuronal or mixed neuronal-glial neoplasm.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muragaki Yoshihiro
Organization Tokyo Women's Medical University
Division name Department of Neurosurgery, Neurological Institute
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Women's Medical University
Division name Department of Neurosurgery, Neurological Institute
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kizawa Memorial Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 08 Day
Last modified on
2012 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005769

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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