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Completed

NCT Number: NCT02651701

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MR-PET

Procedure

whole body MR-PET with dedicated liver+rectal protocol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up

    Time frame: 18 months

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jan 11, 2016
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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