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Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MR/PET
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring MR/PET, Non-small cell lung cancer (NSCLC)

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: > 20 years old.
  2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
  3. Patients voluntarily to join this study and signed informed consents.

Exclusion Criteria:

  1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
  2. Patients with claustrophobia to MRI examination
  3. Patients who are reluctant to comply with follow-up and subsequent examination
  4. The other condition that do not meet the inclusion criteria.
  5. Pregnancy.
  6. Age < 20 years old.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR/PET

Arm Description

hypothesize that MR/PET can have better information than current CT image study

Outcomes

Primary Outcome Measures

Change from Baseline PET/MR parameters at 2 months after treatment

Secondary Outcome Measures

Full Information

First Posted
October 30, 2016
Last Updated
February 14, 2017
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch
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1. Study Identification

Unique Protocol Identification Number
NCT03053804
Brief Title
Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction
Official Title
Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment, Outcome, and Prognosis Prediction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer
Detailed Description
The investigators analyze tumor size、ADCmean、ADCmin、DCE、SUVmax、SUVmin、etc in MR/PET study，to compare its efficacy with other image studies in tumor malignancy grade, systemic involvement detection, treatment outcome after medical target therapy and treatment outcome after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
MR/PET, Non-small cell lung cancer (NSCLC)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR/PET
Arm Type
Experimental
Arm Description
hypothesize that MR/PET can have better information than current CT image study
Intervention Type
Radiation
Intervention Name(s)
MR/PET
Intervention Description
MR/PET with contrast media and FDG-18
Primary Outcome Measure Information:
Title
Change from Baseline PET/MR parameters at 2 months after treatment
Time Frame
2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: > 20 years old. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells) Patients voluntarily to join this study and signed informed consents. Exclusion Criteria: Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves Patients with claustrophobia to MRI examination Patients who are reluctant to comply with follow-up and subsequent examination The other condition that do not meet the inclusion criteria. Pregnancy. Age < 20 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeun-Chung Chang
Phone
02-23123456*65566
Email
ycc5566@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Sen Huang
Phone
02-23123456*65566
Email
yusen0814@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeun-Chung Chang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeun-Chung Chang, MD
Phone
02-23123456*65566
Email
ycc5566@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction

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