Positron Emission Tomography - Computed Tomography (PET-C... | NCT00269373

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

NCT00269373

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

136Actual

Phase

Not provided

Conditions

Unknown Primary Tumor

Interventions

PET-CT

Countries

Denmark

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Dec 22, 2005

First Submission Date that Met QC Criteria

Dec 22, 2005

First Posted Date

Dec 23, 2005Estimated

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

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

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

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.

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

136Actual

Name	Type	Description	Arm Group Labels	Other Names
PET-CT	Procedure	no drugs included

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with unknown tumors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gedske Daugaard	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009382	Neoplasms, Unknown Primary

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided