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Clinical Trials/NL-OMON30564
NL-OMON30564Not yet recruitingPhase 4

The use of USPIO enhanced MRI in the assessment of axillary lymph node status in patients with invasive breast cancer - The USPALS study

niversitair Medisch Centrum Sint Radboud0 sites440 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
440
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •- Histologically proven invasive breast cancer
  • •- Surgical removal of at least 1 axillary lymph node will be performed
  • •- Patient must be accessible for treatment
  • •- Patient must provide written informed consent

Exclusion Criteria

  • •- Patient age < 18
  • •- Karnofsky score = 70 or <70
  • •- Pregnant or lactating women
  • •- Patients with conta-indications for MRI scanning (e.g. pacemaker, claustrophobia, ferromagnetic objects in the eyes or brain)
  • •- Patients with contra-indications for the use of USPIO based contrast agents or dextran (e.g. known allergy)
  • •- Male gender

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

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