Preoperative Prediction of of Thymic Epithelial Tumors by... | NCT03212027

Studies
Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging

NCT03212027

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Jul 18, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Thymic Epithelial Tumor

Interventions

Not provided

Countries

Not provided

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2017Estimated

Primary Completion Date

Jan 1, 2018Estimated

Completion Date

May 1, 2018Estimated

First Submitted Date

Jul 6, 2017

First Submission Date that Met QC Criteria

Jul 6, 2017

First Posted Date

Jul 11, 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

Jul 13, 2017

Last Update Posted Date

Jul 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a possibility of use of ADCuh to identify the pathological type of tumor.

Detailed Description

Magnetic resonance (MR) diffusion-weighted imaging (DWI) measures water diffusion in biological tissue. The quantification of diffusion is described by the apparent diffusion coefficient (ADC),which largely depends on the number and separation of barriers.Thus, ADC can provide information regarding tissue microstructure.

According to the literature, ADC is also related to cell membrane permeability for water molecules.It is well known that cellular water transport depends on aquaporins (AQPs).In general,the expression of aquaporins might differ in several pathologic disorders. With reference to this fact,we hypothesize that AQPs expression may influence ADC in thymic epithelial tumors(TETs).Therefore,the aim of the present study is to analyze possible associations between ADC from ultra-high b-values and AQPs expression(ADCuh) in TETs and to use ADCuh to identify the pathological type of tumor.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with low-risk thymomas		low-risk thymomas include types A, AB, and B1 thymomas
Patients with high-risk thymomas		high-risk thymomas include types B2 and B3 thymomas
Patients with thymic carcinomas		thymic carcinomas also called types C thymomas

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Different DWI parameters in thymic epithelial tumors		6 months

Secondary Outcomes

Measure	Description	Time Frame
To acquire aquaporins expression level of thymic epithelial tumors		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no use of corticosteroid drugs;
no MRI contraindication;
no infection or fever;
tumor diameter is greater than 2cm.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with thymic epithelial tumors

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
C536905	Thymic epithelial tumor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided