Breast Cancer FemaleNCT03243435
Sienna+MR Long-term Uptake
An observational study of Breast Cancer Female, run by Kantonsspital Baden at 1 site in Switzerland.
Trial summary
In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Native 1,5 Tesla breast MRI
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Apr 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all 34 patients from the previous study are included
Who may be able to join
- participation in previous study
- informed consent
- no contraindications for MRI scan
Who cannot join
- contraindications for MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers
In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.
- Conditions
- Breast Cancer Female
- Being tested
- Native 1,5 Tesla breast MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native 1,5 Tesla breast MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Native 1,5 Tesla breast MRI group | From all patients a 1,5 Tesla MRI of the breast will be obtained Receives: Procedure: Native 1,5 Tesla breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
I) Analysis if the supraparamegnetic Tracer is still detectable
Analysis by two expert radiologists
Measured: 04/2017
Secondary outcomes (1)
Analysis to which degree of impairment of Imaging is detected
Description as "no impairment", impairment, but Interpretation of Images possible", "impairment, Image Interpretation impossible"
Measured: 04/2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Leo, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243435
- Sponsor's protocol ID
- 2016-00808
- Other IDs
- 2016
- Status last verified
- Aug 2017
- First submitted
- 5 Jul 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers
- ClinicalTrials.gov ID
- NCT03243435
- Acronym / sponsor ID
- 2016-00808
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Aug 2017 (actual)
- 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.
In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Native 1,5 Tesla breast MRI group | – | Procedure: Native 1,5 Tesla breast MRIFrom all patients a 1,5 Tesla MRI of the breast will be obtained |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all 34 patients from the previous study are included
Key inclusion criteria (3 listed)
- participation in previous study
- informed consent
- no contraindications for MRI scan
Key exclusion criteria (1 listed)
- contraindications for MRI scan
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 |
|---|---|---|
| Native 1,5 Tesla breast MRI | Procedure or surgery | Native 1,5 Tesla breast MRI group |
Primary outcome
I) Analysis if the supraparamegnetic Tracer is still detectable
Time frame: 04/2017
Analysis by two expert radiologists
1 secondary outcome
Analysis to which degree of impairment of Imaging is detected
Time frame: 04/2017
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 9 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Female, run by Kantonsspital Baden at 1 site in Switzerland.
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 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 9 Aug 2017. 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 Switzerland. 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.
What does the primary outcome measure?
I) Analysis if the supraparamegnetic Tracer is still detectable (time frame: 04/2017). 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 9 Aug 2017.