Breast CancerWBMRINCT02183597
Whole-body MRI for the Detection of Metastasis
An observational study of Breast Cancer and Metastases, run by Norwegian University of Science and Technology.
Trial summary
Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Breast Cancer, Metastases
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- 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 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women in Mid Norway living with advanced breast cancer
Who may be able to join
- Cancer patient
Who cannot join
- Poor general condition
- Pacemaker or other MRI contraindications
About this study
Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients.
- Conditions
- Breast Cancer, Metastases
- Keywords
- Magnetic Resonance Imaging, Data Accuracy, Reproducibility of Results, Diagnosis
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced breast cancer | Women with advanced breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of metastasis in skeleton
Number of skeleton metastasis will be assessed at the regular clinical follow-up of breast cancer patients with metastatic disease
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beathe Sitter, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183597
- Sponsor's protocol ID
- STUC-2013-WBMRI-Sitter
- Acronym
- WBMRI
- Status last verified
- Aug 2016
- First submitted
- 16 May 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body MRI for the Detection of Metastasis
- ClinicalTrials.gov ID
- NCT02183597
- Acronym / sponsor ID
- WBMRI / STUC-2013-WBMRI-Sitter
- Conditions
- Breast Cancer, Metastases
- Keywords
- Magnetic Resonance Imaging, Data Accuracy, Reproducibility of Results, Diagnosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Jul 2014 (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.
Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced breast cancer | – | –Women with advanced breast cancer |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in Mid Norway living with advanced breast cancer
Key inclusion criteria (1 listed)
- Cancer patient
Key exclusion criteria (2 listed)
- Poor general condition
- Pacemaker or other MRI contraindications
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
Number of metastasis in skeleton
Time frame: Baseline and after 6 months
Number of skeleton metastasis will be assessed at the regular clinical follow-up of breast cancer patients with metastatic disease
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 10 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Beathe Sitter, PhD principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastases, run by Norwegian University of Science and Technology.
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 2 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Number of metastasis in skeleton (time frame: Baseline and after 6 months). It is what the study was designed to measure, not a finding.
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 10 Aug 2016.