NCT02547610

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

September 10, 2015

Last Update Submit

May 14, 2017

Conditions

Keywords

MR/PET in the evaluationpatients

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

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Tiffany Ting-Fang Shih, M.D.

    Department of Medical Imaging, National Taiwan University Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Fang Shih, MD

CONTACT

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

Locations