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

Tracking Information
First Submitted Date	December 22, 2005
First Posted Date	December 23, 2005
Last Update Posted Date	February 22, 2012
Study Start Date	December 2005
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00269373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors
Official Title	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	Observational
Study Design	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	Unknown Primary Tumor
Intervention	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	Completed
Actual Enrollment; (submitted: December 22, 2005)	136
Original Enrollment	Same as current
Actual Study Completion Date	February 2012
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria	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	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Denmark
Removed Location Countries
Administrative Information
NCT Number	NCT00269373
Other Study ID Numbers	01 283694
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gedske Daugaard, Rigshospitalet, Denmark
Study Sponsor	Rigshospitalet, Denmark
Collaborators	Not Provided
Investigators	Principal Investigator: Gedske Daugaard Rigshospitalet, Denmark
PRS Account	Rigshospitalet, Denmark
Verification Date	February 2012