Rectal Cancer Staging Using Whole Body MR-PET

December 10, 2019 updated by: Jeong Hee Yoon, Seoul National University Hospital

Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET

The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients newly diagnosed with rectal cancer.

Description

Inclusion Criteria:

  1. Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
  2. Patients who sign informed consent.

Exclusion Criteria:

  1. Patients who are contraindication for CECT
  2. Patients who are contraindication for MRI/CE-MRI
  3. patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
  4. Patients who were already diagnosed with an active other cancers.
  5. Premenopausal female patients who are pregnant.
  6. Patients with fasting serum glucose level (>200mg/dL) on blood glucose meter prior to WB MR-PET.
  7. Patients who are physically compromised to undergo WB MR-PET.

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
Measure Description
Time Frame
the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
Time Frame: 12 months
the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of recommendation for further workup after examination
Time Frame: 12 months
incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared.
12 months
concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.
Time Frame: 12 months
12 months
concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up
Time Frame: 18 months
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transient dyspnea
Time Frame: within an hour after MR contrast media administration
incidence of transient dyspnea which can occur after MR contrast agent administration and spontaneously regressed.
within an hour after MR contrast media administration

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

August 8, 2017

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (ESTIMATE)

January 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRPET-CRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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