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NCT03243435 Clinical Trial

Sienna+MR Long-term Uptake

Breast Cancer Female Clinical Trial

Official title:
Feasibility of Breast MRI After Sentinel Procedure for Breast Cancer With Superparamagnetic Tracers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03243435
Other study ID # 2016-00808
Secondary ID
Status Completed
Phase N/A
First received July 5, 2016
Last updated August 3, 2017
Start date July 2016
Est. completion date April 2017

Study information
Verified date August 2017
Source Kantonsspital Baden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility inclusion:

- participation in previous study

- informed consent

- no contraindications for MRI scan

exclusion:

- contraindications for MRI scan

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Native 1,5 Tesla breast MRI

Locations
Country Name City State
Switzerland Kantonsspital Baden Baden Aargau

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary I) Analysis if the supraparamegnetic Tracer is still detectable Analysis by two expert radiologists 04/2017
Secondary Analysis to which degree of impairment of Imaging is detected Description as "no impairment", impairment, but Interpretation of Images possible", "impairment, Image Interpretation impossible" 04/2017
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