Understanding a New Surgical Method for Ductal Cancer in Situ Patients
NCT04722692 · RecruitingThis trial looks at a method called delayed sentinel lymph node dissection for patients with ductal cancer in situ (DCIS) or unclear breast lesions. The goal is to see how well a special tracer, superparamagnetic iron oxide (SPIO), works when it is injected during surgery. The study will help determine if this method can avoid unnecessary surgery for patients who do not have invasive cancer upon final testing.
Locations and contact
This trial is running at 9 locations in 3 countries. All of them are currently recruiting.
United States1 location · 1 recruiting
- Baylor College Of MedicineHouston, TexasRecruiting
Sweden7 locations · 7 recruiting
- Falun LasarettFalun, Dalarna CountyRecruiting
- Linköping University HospitalLinköping, Östra GötalandRecruiting
- Sahlgrenska University HospitalGothenburg, Västra Götaland CountyRecruiting
- Skåne University HospitalLund, Skåne CountyRecruiting
- Uppsala University HospitalUppsalaRecruiting
- Västmanland County HospitalVästerås, Västmanland CountyRecruiting
- Växjö County HospitalVaxjo, Kronoberg CountyRecruiting
Hong Kong1 location · 1 recruiting
- The University of Hong Kong-Shenzhen HospitalHong KongRecruiting
Who can join
Women aged 18 and older with a preoperative diagnosis of DCIS or unclear lesions may join. This includes those who are having a mastectomy or other specific breast procedures. Some women will not be able to join if they have allergies to certain substances, are pregnant, or have certain health conditions. The trial team will confirm eligibility for each participant.
What happens during the trial
Participants will be randomly placed into two groups. One group will receive the SPIO tracer first during surgery, while the other group will use a different tracer during a second operation if invasive cancer is found later. Both groups will have their lymph nodes checked to see if the cancer has spread after the initial surgery.
The trial team
The trial is led by Uppsala University, with Dr. Andreas Karakatsanis as the principal investigator. Several hospitals in Sweden and one in Hong Kong are also involved in this study.
Important dates
The trial started on March 1, 2020, and is currently recruiting new participants. It is expected to finish by December 30, 2027.
Additional information
This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. About 500 participants are expected to join, and the trial is regulated by the FDA.
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