Cervical CancerNCT00451945
New Indications for Ultrasound in the Staging of Cervical Cancer
A study testing biopsy and 3d-ultrasound and fusion of UL and PET/CT in people with Cervical Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer. 1. 3-D-ultrasound of the tumour to estimate its volume and local spread 2. Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- biopsy and 3d-ultrasound and fusion of UL and PET/CT
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Mar 2008
- Phase
- Interventional
- 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 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Cervical cancer,
- PET/CT pos. lymph nodes,
- Patients over 18 years old
Who cannot join
- Pregnancy,
- Lactating,
- Diabetic
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen univercity hospital, Department of Radiology, section of ultrasound
Copenhagen, 2100
About this study
The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.
- 3-D-ultrasound of the tumour to estimate its volume and local spread
- Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.
- Conditions
- Cervical Cancer
- Being tested
- biopsy, 3d-ultrasound and fusion of UL and PET/CT
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
3d-ultrasound and fusion of UL and PET/CTDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Michael B Nielsen, MDSc, Principal investigator, Department of radiology, section of ultrasound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451945
- Sponsor's protocol ID
- H-KF 2007-004
- Status last verified
- Jun 2008
- First submitted
- 23 Mar 2007
- Last updated
- 18 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Indications for Ultrasound in the Staging of Cervical Cancer
- ClinicalTrials.gov ID
- NCT00451945
- Acronym / sponsor ID
- H-KF 2007-004
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Mar 2008
- First posted
- 26 Mar 2007 (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.
The purpose is to investigate and evaluate two new diagnostic methods using ultrasound in the staging of cervical cancer.
- 3-D-ultrasound of the tumour to estimate its volume and local spread
- Fusion of PET/CT and ultrasound to evaluate and biopsy lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cervical cancer,
- PET/CT pos. lymph nodes,
- Patients over 18 years old
Key exclusion criteria (3 listed)
- Pregnancy,
- Lactating,
- Diabetic
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 |
|---|---|---|
| biopsy | Procedure or surgery | – |
| 3d-ultrasound and fusion of UL and PET/CT | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2008.
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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.
Michael B Nielsen, MDSc principal investigator
Department of radiology, section of ultrasound
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy and 3d-ultrasound and fusion of UL and PET/CT in people with Cervical Cancer, 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 3 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: withdrawn, as of the sponsor's last update on 18 Jun 2008. 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 was withdrawn before enrolling participants, so there are no results.
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 18 Jun 2008.