Gastric AdenocarcinomaEarly Phase 1NCT01794026
Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients
A Early Phase 1 study testing diffusion weighted magnetic resonance imaging in people with Gastric Adenocarcinoma, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- diffusion weighted magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Dec 2013
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric adenocarcinoma proven by endoscopic biopsy;
- application of both computed tomography and diffusion weighted magnetic resonance imaging;
- standard gastrectomy and a D2 lymph node dissection;
- desire to attend the study protocol
Who cannot join
- preoperative neoadjuvant therapy;
- metastatic disease;
- undesired reaction to attend the study protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
Istanbul, 34093
About this study
Official title: Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively
Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures.
Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.
Read the detailed description
- proven endoscopic diagnosis of gastric adenocarcinoma
- for staging purposes, computed tomography for all patients
- evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes
- to state precisely resectable patients according to computed tomography and anesthetic evaluation
- evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes
- standard gastrectomy and D2 lymph node dissection
- mapping of the lymph nodes after taking the specimen out
- histopathological diagnosis of the lymph nodes and mapping
- comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis
- Conditions
- Gastric Adenocarcinoma
- Being tested
- diffusion weighted magnetic resonance imaging
- Keywords
- diffusion weighted, magnetic resonance imaging, surgery, histopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion weighted magnetic resonance imagingProcedure or surgery
for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients
| Study group | Role | What they receive |
|---|---|---|
| diffusion MRI | Experimental | histopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging Receives: Procedure: diffusion weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794026
- Sponsor's protocol ID
- DWMRIGASTADENO
- Status last verified
- Dec 2013
- First submitted
- 15 Feb 2013
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively
- ClinicalTrials.gov ID
- NCT01794026
- Acronym / sponsor ID
- DWMRIGASTADENO
- Conditions
- Gastric Adenocarcinoma
- Keywords
- diffusion weighted, magnetic resonance imaging, surgery, histopathology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2013 (estimated)
- 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.
Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures.
Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.
Detailed description
- proven endoscopic diagnosis of gastric adenocarcinoma
- for staging purposes, computed tomography for all patients
- evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes
- to state precisely resectable patients according to computed tomography and anesthetic evaluation
- evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes
- standard gastrectomy and D2 lymph node dissection
- mapping of the lymph nodes after taking the specimen out
- histopathological diagnosis of the lymph nodes and mapping
- comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diffusion MRI | Experimental | Procedure: diffusion weighted magnetic resonance imaginghistopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- gastric adenocarcinoma proven by endoscopic biopsy;
- application of both computed tomography and diffusion weighted magnetic resonance imaging;
- standard gastrectomy and a D2 lymph node dissection;
- desire to attend the study protocol
Key exclusion criteria (3 listed)
- preoperative neoadjuvant therapy;
- metastatic disease;
- undesired reaction to attend the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion weighted magnetic resonance imagingfor diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients | Procedure or surgery | diffusion MRI |
Primary outcome
efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
Time frame: one year
to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing diffusion weighted magnetic resonance imaging in people with Gastric Adenocarcinoma, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes (time frame: one year). 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 1 Mar 2017.