Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gedske Daugaard, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00269373

First received: December 22, 2005

Last updated: February 20, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2005

Last Updated Date

February 20, 2012

Start Date ^ICMJE

December 2005

Primary Completion Date

February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00269373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors

Official Title ^ICMJE

PET-CT Scan as a Diagnostic Method in Unknown Primary Tumors

Brief Summary

Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with unknown primary tumors? Can information obtained with PET-CT replace other clinical and radiological investigations? Is PET/CT cost-effective?

Detailed Description

Patients who fulfill the international definition of unknown primary tumors can be included, except:

Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included.
Women with adenocarcinoma in lymph nodes in the axilla will not be included.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with unknown tumors

Condition ^ICMJE

Unknown Primary Tumor

Intervention ^ICMJE

Procedure: PET-CT

no drugs included

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

136

Completion Date

February 2012

Primary Completion Date

February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Unknown primary tumors

Exclusion Criteria:

Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included
Women with adenocarcinoma in lymph nodes in the axilla will not be included

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00269373

Other Study ID Numbers ^ICMJE

01 283694

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Gedske Daugaard, Rigshospitalet, Denmark

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gedske Daugaard

Rigshospitalet, Denmark

PRS Account

Rigshospitalet, Denmark

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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