UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006176 |
|---|---|
| Receipt number | R000007299 |
| Scientific Title | Evaluation of mediastinal LNs in lung cancer using Discovery MR750 3.0T eDWI |
| Date of disclosure of the study information | 2011/08/22 |
| Last modified on | 2012/08/21 06:30:59 |
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Basic information
Public title
Evaluation of mediastinal LNs in lung cancer using Discovery MR750 3.0T eDWI
Acronym
MRI study of mediastinal lymphadenopathies
Scientific Title
Evaluation of mediastinal LNs in lung cancer using Discovery MR750 3.0T eDWI
Scientific Title:Acronym
MRI study of mediastinal lymphadenopathies
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to prospectively determine the diagnostic accuracy of eDWI on 3T MRI in the staging of thoracic lymph nodes in patients with lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eDWI, ADC values of LNs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
LK
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Preoperative lung cancer patients
Perform an MRI prior to surgery for lung cancer, 30 patients were deemed operable by CT scan.
EBUS can be enforced if the evaluation of hilar and mediastinal lymph nodes by MRI prior to enforcement as applied to artifacts EBUS.
Control group
Five healthy volunteers with no history of lung cancer.
Key exclusion criteria
Exclusion criteria
To patients who meet any of the following criteria.
1) Patients with a history of lung cancer surgery.
2) Patients with cardiac arrhythmias.
3) Patients have difficulty breathing stops for 30 seconds.
4) Patients with a pacemaker embedded in the body, such as precision instruments.
5) heart failure, respiratory failure, liver failure, patients with renal insufficiency.
6) Patients with claustrophobia.
7) Patients not maintain a supine rest for 30 minutes.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Motoori MD |
Organization
Chiba University Hospital
Division name
Radiology
Zip code
Address
Chiba, Inohana, 1-8-1
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate school of medicine and school of medicine,Chiba University
Division name
IRB
Zip code
Address
TEL
Homepage URL
igaku-rinri@office.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2012 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007299
