Coregistration of 18F-FDG-PET and MRI in the Staging of P... | NCT00604266

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

NCT00604266

Sponsor

University of Toronto

Status

Withdrawn

Last Update Posted

May 4, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cholangiocarcinoma

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2008Estimated

Completion Date

Aug 2008Estimated

First Submitted Date

Jan 17, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Jan 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2017

Last Update Posted Date

May 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ur Metser, Division Head, Molecular Imaging, Joint Department of Medical Imaging, University of TorontoPrincipal Investigator

Lead Sponsor

University of TorontoOTHER

Collaborators

Name	Class
University Health Network, Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1		10-15 patients with potentially resectable hiilar cholangiocarcinoma

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ur Metser, MD	U of Toronto, UHN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHN - Princess Margaret Hospital		Toronto	Ontario	M5G 1Z5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided