UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004846 |
|---|---|
| Receipt number | 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 | 2023/12/12 11:54:30 |
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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
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
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 06 | Day |
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
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005769
