Clinical Application of MR-PET in Non-small Cell Lung Can... | NCT03053804

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

NCT03053804

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Feb 15, 2017Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Non-small Cell Lung Cancer

Interventions

MR/PET

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 30, 2016

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2017

Last Update Posted Date

Feb 15, 2017Actual

Name	Class
National Taiwan University Hospital, Yun-Lin Branch	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MR/PET	Experimental	hypothesize that MR/PET can have better information than current CT image study	Radiation: MR/PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR/PET	Radiation	MR/PET with contrast media and FDG-18	MR/PET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline PET/MR parameters at 2 months after treatment		2 months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeun-Chung Chang	Contact	02-23123456*65566		ycc5566@ntu.edu.tw
Yu-Sen Huang	Contact	02-23123456*65566		yusen0814@gmail.com

Overall Officials

Name	Affiliation	Role
Yeun-Chung Chang, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taipei	100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided