UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016312 |
|---|---|
| Receipt number | R000018919 |
| Scientific Title | Standardization of the MRI scanning method in the diagnosis of N-factor in primary lung cancer |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2023/08/01 16:16:50 |
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Basic information
Public title
Standardization of the MRI scanning method in the diagnosis of N-factor in primary lung cancer
Acronym
Standardization of the MRI scanning method in the diagnosis of N-factor in primary lung cancer
Scientific Title
Standardization of the MRI scanning method in the diagnosis of N-factor in primary lung cancer
Scientific Title:Acronym
Standardization of the MRI scanning method in the diagnosis of N-factor in primary lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracy of N-factor in primary lung cancer between MRI imaging (DWI MRI, STIR) and FDG-PET/CT at multi-center trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic accuracy of N-factor (N0/1/2) is compared between MRI imaging (DWI, STIR) and FDG-PET/CT for each referring the pathological diagnosis as gold standards.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients planned for surgery with diagnosis of primary lung cancer or suspected.
2) Aged 20 or older
3) All subjects must be fully informed about the study and give consent
4) The patient who carries out FDG-PET/CT within 2 months scheduled date of surgery.
Key exclusion criteria
1) Patients who was already enrolled in this study
2) Patient of contraindication to an MRI (e.g. after implantation of a pacemaker)
3) Patient who couldn't carry out FDG-PET/CT before the oparation
4) Patient with a history of an operation of primary lung cancer
5) Patient with a history of radiation irradiation to a thorax
6) During medication by diabetes or blood glucose level >=150mg/dL
7) Pregnant, parturient, or breastfeeding women
8) Patients who was diagnosis of small cell lung cancer, a benign tumor, and other nonneoplastic diseases in pathology organizational diagnosis
9) Any others judged ineligible as a subject by the investigator/sub-investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidetake |
| Middle name | |
| Last name | Yabuuchi |
Organization
Kyusyu University
Division name
Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL
092-642-6727
h-yabu@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetake |
| Middle name | |
| Last name | Yabuuchi |
Organization
Kyusyu University
Division name
Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL
092-642-6727
Homepage URL
h-yabu@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyusyu University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin
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
Kyushu University
Address
Maidashi, Higashi-ku, Fukuoka
Tel
+81-92-642-6727
h-yabu@med.kyushu-u.ac.jp
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
| 2015 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
http://www.radiol.med.kyushu-u.ac.jp/research-info
Publication of results
Unpublished
Result
URL related to results and publications
http://www.radiol.med.kyushu-u.ac.jp/research-info
Number of participants that the trial has enrolled
158
Results
N-stage per patient
There was no significant difference in sensitivity and accuracy between three modalities by two readers.
However, specificity of FDG-PET/CT in reader 2 were superior to those of DWI and STIR in reader 1.
N-stage per LN station
Sensitivity of DWI in reader 2 was superior to that of FDG-PET/CT in reader 2.
Specificity and accuracy of FDG-PET/CT in reader 2 was superior to those of STIR and DWI in both readers.
Results date posted
| 2023 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Histopathological diagnosis of primary lesion (n=158)
Adenocarcinoma 124
Squamous cell carcinoma 24
Large cell carcinoma 6
Adenosquamous cell carcinoma 4
Pathological N stage
N0 118
N1 18
N2 21
N3 1
75% (118/158) patients were negative, and 25% (40/158) had positive lymph node metastasis histopathologically.
Participant flow
Registered patients (n=178)
Excluded if
The imaging data was inappropriate (n=9) or impossible to be imported (n=3)
Excluded if
The duration between MRI and PET > 2 months(n=4) or histology is not NSCLC (n=4)
Final cohort (n=158)
Adverse events
N/A
Outcome measures
Diagnostic value per patient and per LN station
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are registered non-selectively.
Patient background, FDG-PET/CT and MR imaging information are recorded, and statistical analysis of the data is carried out.
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018919
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
