Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 1, 2020

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2027

Conditions
DCISBreast CancerBreast NeoplasmsSentinel Lymph Node
Interventions
DIAGNOSTIC_TEST

Delayed SLND

"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed.~SLND is divided into the following steps:~1. Transcutaneous signal~2. Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal~3. SLN identification in situ~4. SLN excision and signal ex vivo~5. Background axillary counts. For step d the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer."

DIAGNOSTIC_TEST

Late SLND

"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed.~SLND is divided into the following steps:~1. Transcutaneous signal~2. Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal~3. SLN identification in situ~4. SLN excision and signal ex vivo~5. Background axillary counts. For step d the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer."

Trial Locations (9)

2242

RECRUITING

Skåne University Hospital, Lund

35434

RECRUITING

Växjö County Hospital, Vaxjo

41346

RECRUITING

Sahlgrenska University Hospital, Gothenburg

58191

RECRUITING

Linköping University Hospital, Linköping

72335

RECRUITING

Västmanland County Hospital, Västerås

75185

RECRUITING

Uppsala University Hospital, Uppsala

77030

RECRUITING

Baylor College Of Medicine, Houston

791131

RECRUITING

Falun Lasarett, Falun

Unknown

RECRUITING

The University of Hong Kong-Shenzhen Hospital, Hong Kong

All Listed Sponsors
collaborator

Västmanlands Hospital, Västerås, Sweden

UNKNOWN

collaborator

Sahlgrenska University Hospital

OTHER

collaborator

University Hospital, Linkoeping

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

Blekinge County Council Hospital

OTHER

collaborator

Växjö Hospital, Växjö, Sweden

UNKNOWN

collaborator

The University of Hong Kong-Shenzhen Hospital

OTHER

collaborator

Norrlands University Hospital

OTHER

collaborator

Dalarna County Hospital, Falun, Sweden

UNKNOWN

collaborator

Baylor College of Medicine

OTHER

lead

Uppsala University

OTHER

NCT04722692 - Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ | Biotech Hunter | Biotech Hunter