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


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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name