CUP Project PET/CT

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Charlotte Krogh Rask, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01469026
First received: October 28, 2011
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

The purpose is to elucidate the value of PET/CT applied early in the work-up of patients with a metastasising cancer of an unknown primary tumor.

The management of patients with metastasising cancer of unknown primary often includes various and a large number of radiographic studies and invasive procedures, but the occult primary tumor is detected in less than 20%.

Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive diagnostic procedures are carried out. The outcome may be higher tumor detection rate and quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number of the patients will receive treatment aimed at the correct diagnosis. Therefore, a prospective cost-effectiveness analysis is warranted.


Condition Intervention Phase
Metastasising Cancer of Unknown Primary
Radiation: PET/CT or Conventional diagnostics including CT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: The Value of Early PET/CT in Patients With Metastasising Cancer of Unknown Primary

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 1. Detection of primary tumor possible: yes/no (primary endpoint) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    The outcome is evaluated based on the project specified PET/CT compared to conventional diagnostic investigations including CT. - The evaluation of the PET/CT scan, primary tumor/non-primary tumor, is obtained by consensus of two nuclear medicine physicians with experience in PET/CT.


Secondary Outcome Measures:
  • 2. Time frame from inclusion into the study to detection of primary tumor. [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    The time frame is determined by the number of days from the date of inclusion to the date of description for the PET/CT or the date of description for conventional CT.

  • 3. Time frame from inclusion into the study to referral to palliative or curative treatment. [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    The time frame is determined by the number of days from the date of inclusion to the date of description for the PET/CT or the date of description for conventional CT.

  • 4. Time frame from inclusion into the study to end of follow-up or death. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Patients are followed till death or 36 months post inclusion.

  • 5. Total score of Quality of Life instrument "SF-36". [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Quality of life evaluation is performed at 3-6-12 and 36 months.


Estimated Enrollment: 220
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early PET/CT Radiation: PET/CT or Conventional diagnostics including CT

Radiation:

PET/CT. 4 MBq/kg (max. 400 MBq) 18F-flour-deoxyglucosegiven iv. 60 min. before PET/CT scan.

CT. iv.contrast medium (Ultravist 370 mg I/ml).

Other Names:
  • Radiation:
  • Positron emission tomography
  • Computed tomography
Active Comparator: Conventional diagnostics including CT Radiation: PET/CT or Conventional diagnostics including CT

Radiation:

PET/CT. 4 MBq/kg (max. 400 MBq) 18F-flour-deoxyglucosegiven iv. 60 min. before PET/CT scan.

CT. iv.contrast medium (Ultravist 370 mg I/ml).

Other Names:
  • Radiation:
  • Positron emission tomography
  • Computed tomography

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy proven cancer without identified origin at the time of examination.
  2. Patients admitted to but not fitting into existing cancer package programs.
  3. Patients with very serious, but unknown, disease, which might be cancer.

Exclusion Criteria:

  1. Patient belongs to one of the existing cancer packages - state which one.
  2. Suspected metastasis in the liver.
  3. Suspected metastasis in the brain.
  4. Prior PET/CT imaging showing multiple metastases with no identifiable primary.
  5. Cancer treatment already started.
  6. Estimated inability to collaborate - state reason.
  7. Prior malignant disease.
  8. Pregnancy.
  9. The patient cannot read and understand Danish.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469026

Contacts
Contact: Charlotte Rask, Medical Doctor (+45) 30161459 charlotte.rask@ouh.regionsyddanmark.dk
Contact: Poul Flemming Hoeilund-Carlsen, Professor (+45)30161445 pfhc@ouh.regionsyddanmark.dk

Locations
Denmark
Depatment of Nuclearmedicine Not yet recruiting
Odense, Denmark, 5000
Contact: Charlotte Rask, Medical doctor    (+45)30161459    charlotte.rask@ouh.regionsyddanmark.dk   
Principal Investigator: Charlotte Rask, Medical doctor         
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Charlotte Krogh Rask, Medical doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01469026     History of Changes
Other Study ID Numbers: K36
Study First Received: October 28, 2011
Last Updated: November 9, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on October 23, 2014