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Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study (PET/MRCP)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00604266
First received: January 17, 2008
Last updated: June 26, 2008
Last verified: June 2008
History of Changes
  Purpose

To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.


Condition
Cholangiocarcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study.

Further study details as provided by University of Toronto:

Estimated Enrollment: 15
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
10-15 patients with potentially resectable hiilar cholangiocarcinoma

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Fifteen patients with potentially resectable hilar cholangiocarcinomas, as determined by conventional imaging modalities, will be recruited. In order to minimize false positive uptake of 18F-FDG due to inflammatory changes, patients will be recruited either before biliary stenting, or after biliary stenting if there is no clinical evidence of active cholangitis.

Criteria

Inclusion Criteria:

  • Hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic CT scan of the liver) and thought to be potentially resectable.

Exclusion Criteria:

  • Biliary drain inserted.
  • Contraindication for MRI.
  • Pregnant or breast-feeding.
  • Uncontrolled diabetes (over 9.7 mmol/L).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604266

Locations
Canada, Ontario
UHN - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Investigators
Principal Investigator: Ur Metser, MD U of Toronto, UHN
  More Information

No publications provided

Responsible Party: Dr. Ur Metser, UHN
ClinicalTrials.gov Identifier: NCT00604266     History of Changes
Other Study ID Numbers: 07-0216
Study First Received: January 17, 2008
Last Updated: June 26, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Potentially resectable hilar cholangiocarcinoma as per initial imaging studies.
Able to undergo PET/CT and MRI with Gadolinium

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin's Tumor
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013