Thymic Epithelial TumorNCT03212027
Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging
An observational study of Thymic Epithelial Tumor, run by Tang-Du Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thymic Epithelial Tumor
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2017to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with thymic epithelial tumors
Who may be able to join
- no use of corticosteroid drugs;
- no MRI contraindication;
- no infection or fever;
- tumor diameter is greater than 2cm.
Who cannot join
- -
About this study
Official title: Preoperative Prediction of the Pathological Classification of Thymic Epithelial Tumors by Apparent Diffusion Coefficient Using Ultra-high B-values
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.
Read the 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.
- Conditions
- Thymic Epithelial Tumor
- Keywords
- apparent diffusion coefficient, aquaporins
- Medical subject headings
- Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different DWI parameters in thymic epithelial tumors
Measured: 6 months
Secondary outcomes (1)
To acquire aquaporins expression level of thymic epithelial tumors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start31 Jul 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212027
- Sponsor's protocol ID
- 2016SF-211
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prediction of the Pathological Classification of Thymic Epithelial Tumors by Apparent Diffusion Coefficient Using Ultra-high B-values
- ClinicalTrials.gov ID
- NCT03212027
- Acronym / sponsor ID
- 2016SF-211
- Conditions
- Thymic Epithelial Tumor
- Keywords
- apparent diffusion coefficient, aquaporins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 31 Jul 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with thymic epithelial tumors
Key inclusion criteria (4 listed)
- no use of corticosteroid drugs;
- no MRI contraindication;
- no infection or fever;
- tumor diameter is greater than 2cm.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Different DWI parameters in thymic epithelial tumors
Time frame: 6 months
1 secondary outcome
To acquire aquaporins expression level of thymic epithelial tumors
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymic Epithelial Tumor, run by Tang-Du Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different DWI parameters in thymic epithelial tumors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.