UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027127
Receipt number R000031084
Scientific Title Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT
Date of disclosure of the study information 2017/04/25
Last modified on 2022/11/09 11:15:18

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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 or person

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name