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Clinical Trials/NL-OMON30564
NL-OMON30564
Not yet recruiting
Phase 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 enrollmentTBD
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Conditionslymph node metastasistumor positive lymph nodes10006291

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
lymph node metastasis
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
440
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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