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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00604266
First Posted: January 30, 2008
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Ur Metser, University of Toronto
  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.

Resource links provided by NLM:


Further study details as provided by Ur Metser, University of Toronto:

Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ur Metser, Division Head, Molecular Imaging, Joint Department of Medical Imaging, University of Toronto
ClinicalTrials.gov Identifier: NCT00604266     History of Changes
Other Study ID Numbers: 07-0216
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Ur Metser, 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 Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action