MR/PET in the Evaluation of Patients With Esophageal Cancer

May 14, 2017 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. newly diagnosed esophageal cancer patient
  2. age older than 20 years

Exclusion Criteria:

  1. 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.
  2. patient who will receive endoscopic local therapy alone
  3. unable to finish the standard surgical or radiation treatment
  4. history of surgery or radiotherapy to the mediastinum
  5. renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
  6. patient who have the claustrophobic symptoms are also not suitable for this MR examination
  7. pregnancy or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The imaging biomarkers determined by MR-PET
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Tiffany Ting-Fang Shih, M.D., Department of Medical Imaging, National Taiwan University Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 14, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201402050MINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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