NCT00604266

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

January 17, 2008

Last Update Submit

May 1, 2017

Conditions

Cholangiocarcinoma

Keywords

Potentially resectable hilar cholangiocarcinoma as per initial imaging studies.Able to undergo PET/CT and MRI with Gadolinium

Study Arms (1)

1

10-15 patients with potentially resectable hiilar cholangiocarcinoma

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Biliary drain inserted.
  • Contraindication for MRI.
  • Pregnant or breast-feeding.
  • Uncontrolled diabetes (over 9.7 mmol/L).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHN - Princess Margaret Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Ur Metser, MD

    U of Toronto, UHN

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Molecular Imaging, Joint Department of Medical Imaging

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

August 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

CA(1)