MR/PET in the Evaluation of Patients With Esophageal Cancer
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 16, 2017
May 1, 2017
3.6 years
September 10, 2015
May 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The imaging biomarkers determined by MR-PET
1 month
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- newly diagnosed esophageal cancer patient
- age older than 20 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany Ting-Fang Shih, M.D.
Department of Medical Imaging, National Taiwan University Hospital.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
May 1, 2014
Primary Completion
December 1, 2017
Study Completion
April 1, 2018
Last Updated
May 16, 2017
Record last verified: 2017-05