Evaluation of Treatment Response With Integrated MRI/PET... | NCT02550613

Studies
Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma

NCT02550613

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

May 16, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

The imaging biomarkers determined by 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

May 2017

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

May 2014

Primary Completion Date

Apr 2018Estimated

Completion Date

Apr 2018Estimated

First Submitted Date

Sep 14, 2015

First Submission Date that Met QC Criteria

Sep 14, 2015

First Posted Date

Sep 15, 2015Estimated

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

May 14, 2017

Last Update Posted Date

May 16, 2017Actual

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

The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients.

Detailed Description

This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The imaging biomarkers determined by MR-PET	Device	The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients. This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The recurrence rate at 3 months after treatment		3 months

Secondary Outcomes

Measure	Description	Time Frame
The overall survival after treatment		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prior Informed Consent Form
At least one measurable tumor, according to RECIST version 1.1.
Age > 20 years.
ECOG performance status 0 or 1.
Life expectancy > 3 months.
Confirmed Diagnosis of HCC
Adequate renal function (Serum creatinine ≦ 1.5 x upper limit of normal).

Exclusion Criteria:

Age <20 years old
Pregnancy
Contraindication for MRI: claustrophobia or MR non-compatible devices
Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre > 2.0)
History of other malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

We will enroll 100 HCC patients who are admitted for curative or non-curative treatments, including operation, radiofrequency ablation, TACE, target therapy, chemotherapy, or radiotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ting-Fang Shih, MD	Contact	+886-2-23123456	65568	ttfshih@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Bang-Bin Chen, MD	Department of Medical Imaging, National Taiwan University Hospital	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided