Breast CancerNCT00276211
Diffusion Weighted MRI for Lymphnodes in the Axilla
An observational study of Breast Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Dec 2006
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed breast cancer patients, where ultrasound and cytologi has proved one or more malignant lymphnodes in the axilla.
Who cannot join
- Pacemaker metal in the body claustrphobia psychiatry patients pregnancy age below 18 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Radiology, Herlev University Hospital
Herlev, DK 2730
About this study
Official title: Diffusionsvægtet MR Skanning Med Henblik på axillære Lymfeknudemetastaser Hos Patienter Med primær Mammacancer - et Pilotstudie
This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla
- Conditions
- Breast Cancer
- Keywords
- MRI diffusion mamma cancer
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Jakob M Møller, M.Sc., Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276211
- Sponsor's protocol ID
- KA-20051023
- Status last verified
- Jan 2006
- First submitted
- 6 Jan 2006
- Last updated
- 28 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusionsvægtet MR Skanning Med Henblik på axillære Lymfeknudemetastaser Hos Patienter Med primær Mammacancer - et Pilotstudie
- ClinicalTrials.gov ID
- NCT00276211
- Acronym / sponsor ID
- KA-20051023
- Conditions
- Breast Cancer
- Keywords
- MRI diffusion mamma cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Jan 2006 (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.
This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed breast cancer patients, where ultrasound and cytologi has proved one or more malignant lymphnodes in the axilla.
Key exclusion criteria (1 listed)
- Pacemaker metal in the body claustrphobia psychiatry patients pregnancy age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 28 Jan 2009.
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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.
Jakob M Møller, M.Sc. principal investigator
Copenhagen University Hospital at Herlev
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 Breast Cancer, run by Copenhagen University Hospital at Herlev 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 1 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 28 Jan 2009. 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 28 Jan 2009.