Esophageal CancerNCT02547610
MR/PET in the Evaluation of Patients With Esophageal Cancer
An observational study of Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The imaging biomarkers determined by MR-PET
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Apr 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy.Total 80 patients will be recruited and followed after treatment complete for at least two years.
Who may be able to join
- newly diagnosed esophageal cancer patient
- age older than 20 years
Who cannot join
- For the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (MRI) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, Swan-Ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips.
- patient who will receive endoscopic local therapy alone
- unable to finish the standard surgical or radiation treatment
- history of surgery or radiotherapy to the mediastinum
- renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
- patient who have the claustrophobic symptoms are also not suitable for this MR examination
- pregnancy or lactating women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ting-Fang Shih, MD, +886-2-23123456 ext. 65568, ttfshih@ntu.edu.tw
About this study
In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.
Read the detailed description
Total 80 patients will be recruited and followed after treatment complete for at least two years. We will compare the staging accuracy of MR/PET and PET/CT, and also analyze parameters that are predictive of disease recurrence and patient survival.
- Conditions
- Esophageal Cancer
- Being tested
- The imaging biomarkers determined by MR-PET
- Keywords
- MR/PET in the evaluation, patients
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The imaging biomarkers determined by MR-PETDevice
Combining PET and MRI, namely MR/PET, has the benefit of evaluating tissue metabolism with PET and at the same time evaluating tissue morphology/functional information with MR.
What is being measured
The primary outcome is the main question the study is designed to answer.
The imaging biomarkers determined by MR-PET
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Ting-Fang Shih, M.D., Principal investigator, Department of Medical Imaging, National Taiwan University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547610
- Sponsor's protocol ID
- 201402050MINC
- Status last verified
- May 2017
- First submitted
- 10 Sep 2015
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR/PET in the Evaluation of Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02547610
- Acronym / sponsor ID
- 201402050MINC
- Conditions
- Esophageal Cancer
- Keywords
- MR/PET in the evaluation, patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 11 Sep 2015 (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.
In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.
Detailed description
Total 80 patients will be recruited and followed after treatment complete for at least two years. We will compare the staging accuracy of MR/PET and PET/CT, and also analyze parameters that are predictive of disease recurrence and patient survival.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy.Total 80 patients will be recruited and followed after treatment complete for at least two years.
Key inclusion criteria (2 listed)
- newly diagnosed esophageal cancer patient
- age older than 20 years
Key exclusion criteria (7 listed)
- For the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (MRI) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, Swan-Ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips.
- patient who will receive endoscopic local therapy alone
- unable to finish the standard surgical or radiation treatment
- history of surgery or radiotherapy to the mediastinum
- renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
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 |
|---|---|---|
| The imaging biomarkers determined by MR-PETCombining PET and MRI, namely MR/PET, has the benefit of evaluating tissue metabolism with PET and at the same time evaluating tissue morphology/functional information with MR. | Device | – |
Primary outcome
The imaging biomarkers determined by MR-PET
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Tiffany Ting-Fang Shih, M.D. principal investigator
Department of Medical Imaging, National Taiwan University Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 7 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 16 May 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 Taiwan. 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.
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?
Contact Ting-Fang Shih, MD (+886-2-23123456 ext. 65568, ttfshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The imaging biomarkers determined by MR-PET (time frame: 1 month). 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 16 May 2017.