Sienna+MR Long-term Uptake

August 3, 2017 updated by: Cornelia Leo, Kantonsspital Baden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Aargau
      • Baden, Aargau, Switzerland
        • Kantonsspital Baden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

all 34 patients from the previous study are included

Description

inclusion:

  • participation in previous study
  • informed consent
  • no contraindications for MRI scan

exclusion:

  • contraindications for MRI scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Native 1,5 Tesla breast MRI group
From all patients a 1,5 Tesla MRI of the breast will be obtained
Procedure: Native 1,5 Tesla breast MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
I) Analysis if the supraparamegnetic Tracer is still detectable
Time Frame: 04/2017
Analysis by two expert radiologists
04/2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis to which degree of impairment of Imaging is detected
Time Frame: 04/2017
Description as "no impairment", impairment, but Interpretation of Images possible", "impairment, Image Interpretation impossible"
04/2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Baden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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