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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This study has been withdrawn prior to enrollment.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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014