Rectal Cancer Staging Using Whole Body MR-PET

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT02651701
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Primary Completion: 2017-08-08
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of