Unknown Primary TumorNCT00269373
Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors
An observational study of Unknown Primary Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unknown Primary Tumor
- What is being tested?
- PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unknown tumors
Who may be able to join
- Unknown primary tumors
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET-CT Scan as a Diagnostic Method in Unknown Primary Tumors
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?
Read the 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.
- Conditions
- Unknown Primary Tumor
- Being tested
- PET-CT
- Keywords
- Unknown primary tumor, PET-CT
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTProcedure or surgery
no drugs included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unknown Primary TumorStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gedske Daugaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gedske Daugaard, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269373
- Sponsor's protocol ID
- 01 283694
- Status last verified
- Feb 2012
- First submitted
- 22 Dec 2005
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-CT Scan as a Diagnostic Method in Unknown Primary Tumors
- ClinicalTrials.gov ID
- NCT00269373
- Acronym / sponsor ID
- 01 283694
- Conditions
- Unknown Primary Tumor
- Keywords
- Unknown primary tumor, PET-CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unknown tumors
Key inclusion criteria (1 listed)
- Unknown primary tumors
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CTno drugs included | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gedske Daugaard principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unknown Primary Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.