NCT02553031

Brief Summary

This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

September 10, 2015

Last Update Submit

May 14, 2017

Conditions

Colorectal Cancer

Keywords

Application of MR-PET

Outcome Measures

Primary Outcomes (1)

  • The recurrence rate at 1 year after surgery

    1 year

Secondary Outcomes (1)

  • The overall survival at 1 year after surgery

    1 year

Interventions

The imaging biomarkers determined by MR-PETDEVICE

This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

Eligibility Criteria

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

This is a prospective cohort study. Patients with 50 newly diagnosed colorectal cancers and 50 patients with suspicious recurrent colorectal cancers will be enrolled.

You may qualify if:

  • Group 1: Patients with newly diagnosed colorectal cancers
  • Group 2: Patients with suspicious recurrent colorectal cancers

You may not qualify if:

  • Age \<20 or \>90 years old
  • Contraindication for MRI: claustrophobia or MR non-compatible devices
  • Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
  • History of other malignancy
  • Prior arthroplasty of hip (may cause artifacts on MRI)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ting-Fang Shih, M.D.

    Department of Medical Imaging, National Taiwan University Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Fang Shih, MD

CONTACT

+886-2-23123456ttfshih@ntu.edu.tw

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 17, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

TW(1)