Rectal Cancer Staging Using Whole Body MR-PET

NCT02651701 | Completed DMC

• 1 other identifier: MRPET-CRC
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Outcome Measures

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

  the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.

  12 months

Secondary Outcomes (3)

• incidence of recommendation for further workup after examination

  12 months

• concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.

  12 months

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

  18 months

Other Outcomes (1)

• Transient dyspnea

  within an hour after MR contrast media administration

Interventions

MR-PET PROCEDURE

whole body MR-PET with dedicated liver+rectal protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients newly diagnosed with rectal cancer.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Bayer: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Yoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3.

  PMID: 31793850 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeong Hee Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 11, 2016
• Study Start: January 1, 2016
• Primary Completion: August 8, 2017
• Study Completion: November 30, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)