MR/PET in the Evaluation of Patients With Esophageal Cancer

NCT ID: NCT02547610

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-04-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

The imaging biomarkers determined by MR-PET

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Ting-Fang Shih, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Imaging, National Taiwan University Hospital.

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ting-Fang Shih, MD

Role: CONTACT

ttfshih@ntu.edu.tw

+886-2-23123456 ext. 65568

Facility Contacts

Ting-Fang Shih, MD

Role: primary

ttfshih@ntu.edu.tw

+886-2-23123456 ext. 65568

Other Identifiers

201402050MINC

Identifier Type: -

Identifier Source: org_study_id