UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT
Acronym	LOGIK1701
Scientific Title	Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT
Scientific Title:Acronym	LOGIK1701
Region	Japan

Condition
Condition	Pulmonary hamartoma
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We prospectively collect the clinical information that chemical shift MRI was carried out in patients doubting pulmonary hamartoma or pulmonary benign tumor in chest CT in multicenter study and investigate availability of chemical shift MRI for preoperative diagnosis of pulmonary hamartoma by comparing with pathology findings after resection.
Basic objectives2	Others
Basic objectives -Others	Sensitivity and specificity of pulmonary hamartoma diagnosis by chemical shift MRI
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity and specificity of pulmonary hamartoma diagnosis by chemical shift MRI
Key secondary outcomes	Positive predictive value in the range of virtual prevalence, ratio of each operative method (enucleation, wedge resection, segmental resection, lobectomy and others), exploration of cut-off value of signal intensity index.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Chemical shift MRI is carried out in patients who pulmonary hamartoma or benign pulmonary tumor was suspected in chest CT and it is compared between the pathological results after tumor resection and the findings of chemical shift MRI
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients providing the written informed consent. (legal representatives are included in the case of a minor subjects) 2) Patients in whom diagnosis of lung cancer is not confirmed and pulmonary hamartoma or benign pulmonary tumor was doubted in chest CT. In addition, patients with bronchial intervention for bronchial hamartoma are eligible. 3) Patients with 10 mm or more of nodal shadow in minor axis by CT. 4) Patients who agree to enforcement of chemical shift MRI within 3 months after enrollment. 5) Patients who agree to tumor resection within 6 months after chemical shift MRI enforcement. 6) Age >= 18 years of age at the time of enrollment. 7) PS 0 or 1.
Key exclusion criteria	1) Patients with apparent complication of suspicious primary or metastatic pulmonary tumors from imaging diagnosis and progress. 2) Patients with metastatic pulmonary tumor as primary lesion of 1:renal cell carcinoma, 2:hepatic cell carcinoma and 3:liposarcoma (because fat component is included in tumor) and without passed 5 year after occurrence of primary lesion. 3) Any other patients who are regarded as unsuitable for the study by the investigators. 4) Patients who can't medically and mentally have MRI examination 5) Patients who refuse the participation in the study
Target sample size	290

Research contact person
Name of lead principal investigator	1st name Masami Middle name Last name Sato
Organization	Kagoshima University Hospital
Division name	Department of Thoracic Surgery
Zip code	890-8520
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL	099-275-6490
Email	m-sato@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Go Middle name Last name Kamimura
Organization	Kagoshima University Hospital
Division name	Department of Operation
Zip code	890-8520
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL	099-275-6490
Homepage URL
Email	k6474547@kadai.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
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	kagoshima University Hospital institutional review board
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
Tel	099-275-6692
Email	kyufsyomu@kuas.kagoshima-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	2017 Year 04 Month 25 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	109
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	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 25 Day
Date of IRB	2017 Year 03 Month 24 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2023 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 25 Day
Last modified on	2022 Year 11 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031084