MR/PET in the Evaluation of Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

MR/PET in the Evaluation of Patients With Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02547610
• Other study ID #: 201402050MINC
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2015
• Last updated: May 14, 2017
• Start date: May 2014
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: National Taiwan University Hospital
• Contact: Ting-Fang Shih, MD
• Phone: +886-2-23123456
• Email: ttfshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The imaging biomarkers determined by MR-PET		1 month