Functional-three-dimensional Reconstruction of Liver by 9... | NCT01350726

Studies
Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan

NCT01350726

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

May 10, 2011Estimated

Enrollment

0Estimated

Phase

Not provided

Conditions

Cirrhosis
Hepatic Carcinoma

Interventions

Not provided

Countries

China

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 2011

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

Jan 2008

Primary Completion Date

May 2011Actual

Completion Date

Jul 2011Estimated

First Submitted Date

May 8, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 10, 2011Estimated

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 9, 2011

Last Update Posted Date

May 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aims of this study were divided into three parts:

To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy
To probe a new dynamic model of the metabolism of the 99mTc-GSA.
To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical treatment.

Study design:

Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH).

Study arrangement:

This study was consisted of three parts:

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal control		Subjects without liver cirrhosis and normal volunteers.
Cirrhosis group		Subjects with liver cirrhosis.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of CT, ultrasound-B, and/or pathology.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

The subjects were from Peking Union Medical College Hospital from May, 2008 to the end of the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000230	Adenocarcinoma
D002277	Carcinoma

Browse Leaves

Not provided

Browse Branches

Not provided