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Three New Methods for Diagnosing Pancreas Cancer

Primary Purpose

Pancreas Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Ultrasound and contrast agent

About this trial

This is an interventional diagnostic trial for Pancreas Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: suspicion of cancer of the pancreas

Sites / Locations

Copenhagen University HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00259532

First Posted

November 25, 2005

Last Updated

February 25, 2009

Sponsor

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00259532

Brief Title

Three New Methods for Diagnosing Pancreas Cancer

Official Title

Ultrasound With Contrast Agent, 64-Slice-CT and Tumormarkers for Diagnosing, Evaluation of Operability and Treatment Control of Pancreas Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Copenhagen

4. Oversight

5. Study Description

Brief Summary

The purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. The investigators hope to be able to use this effect diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if an increased diagnostic safety can be reached compared to an older CT scanning method. All patients will also be examined for the tumor marker CA 19-9. Further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Ultrasound and contrast agent

Intervention Description

contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: suspicion of cancer of the pancreas

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanne S Grossjohann, MD

Phone

+45 35453419

hannesonder@dadlnet.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael B Nielsen, DMSc

Organizational Affiliation

Department of Radiology, Section of Ultrasound

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University Hospital

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanne S Grossjohann, MD

Phone

+45 35453419

hannesonder@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Hanne S Grossjohann, MD

12. IPD Sharing Statement

Learn more about this trial

Three New Methods for Diagnosing Pancreas Cancer

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