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Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT

Investigation of availability of chemical shift MRI in a nodule shadow doubting pulmonary hamartoma or benign pulmonary tumor in chest CT - LOGIK1701

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027127
Enrollment
290
Registered
2017-04-25
Start date
2017-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hamartoma

Interventions

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

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of pulmonary hamartoma diagnosis by chemical shift MRI

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactGo Kamimura

Kagoshima University Hospital Department of Operation

k6474547@kadai.jp099-275-6490

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026