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Rectal Cancer Staging Using Whole Body MR-PET

NCT ID: NCT02651701

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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MR-PET

whole body MR-PET with dedicated liver+rectal protocol

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Hee Yoon

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Hee Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31793850 (View on PubMed)

Other Identifiers

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MRPET-CRC

Identifier Type: -

Identifier Source: org_study_id