Delayed SLND for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Cancer+3 MoreDelayed SLND - DiagnosticTest
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is investigating the use of superparamagnetic iron oxide nanoparticles as a tracer for delayed sentinel lymph node dissection in patients where upfront axillary surgery is oncologically deemed unnecessary.

Eligible Conditions
  • Breast Cancer
  • Ductal Carcinoma In Situ
  • Sentinel Lymph Node

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 10 years

10 years
Disease free interval
Month 24
Shoulder Arm Morbidity
Month 12
Breast Specific Health Related Quality of Life (HR-QoL)
Cost effectiveness
Health Related Quality of Life (HR-QoL)
Patient reported outcomes and measures
Quality-Adjusted-Life-Years (QALY)
One-time (At operation)
Malignancy rate
Nodal Malignancy rate
Nodal concordance
Per patient concordance
SLND avoidance rate
d-SLND detection rate
l-SLND detection rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Late SLND (RI-first arm)
1 of 2
Delayed SLND (SPIO-first arm)
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: Delayed SLND · No Placebo Group · Phase 3

Delayed SLND (SPIO-first arm)
DiagnosticTest
Experimental Group · 1 Intervention: Delayed SLND · Intervention Types: DiagnosticTest
Late SLND (RI-first arm)
DiagnosticTest
ActiveComparator Group · 1 Intervention: Late SLND · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years

Who is running the clinical trial?

University Hospital, LinkoepingOTHER
166 Previous Clinical Trials
952,211 Total Patients Enrolled
Växjö Hospital, Växjö, SwedenUNKNOWN
Baylor College of MedicineOTHER
923 Previous Clinical Trials
5,987,549 Total Patients Enrolled
7 Trials studying Breast Cancer
685 Patients Enrolled for Breast Cancer
Norrlands University HospitalOTHER
10 Previous Clinical Trials
2,378 Total Patients Enrolled
Skane University HospitalOTHER
152 Previous Clinical Trials
80,963 Total Patients Enrolled
Sahlgrenska University Hospital, SwedenOTHER
365 Previous Clinical Trials
277,982 Total Patients Enrolled
3 Trials studying Breast Cancer
510 Patients Enrolled for Breast Cancer
The University of Hong Kong-Shenzhen HospitalOTHER
12 Previous Clinical Trials
4,696 Total Patients Enrolled
Blekinge County Council HospitalOTHER
10 Previous Clinical Trials
1,903 Total Patients Enrolled
Uppsala UniversityLead Sponsor
423 Previous Clinical Trials
2,536,478 Total Patients Enrolled
9 Trials studying Breast Cancer
5,663 Patients Enrolled for Breast Cancer
Västmanlands Hospital, Västerås, SwedenUNKNOWN
Dalarna County Hospital, Falun, SwedenUNKNOWN
Andreas Karakatsanis, PhDPrincipal Investigator - Uppsala University
Uppsala University
1 Previous Clinical Trials
230 Total Patients Enrolled
1 Trials studying Breast Cancer
230 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy.