Rectal Cancer Staging Using Whole Body MR-PET

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651701
• Other study ID #: MRPET-CRC
• Status: Completed
• Start date: January 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 30, 2019
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• MR-PET
whole body MR-PET with dedicated liver+rectal protocol

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transient dyspnea	incidence of transient dyspnea which can occur after MR contrast agent administration and spontaneously regressed.	within an hour after MR contrast media administration
Primary	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	incidence of recommendation for further workup after examination	incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared.	12 months
Secondary	concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.		12 months
Secondary	concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up		18 months