Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722692
Status:
RECRUITING
Last Update Posted:
2023-08-03
First Post:
2020-12-23
Brief Title:
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it An Open-label Phase 3 Randomised Controlled Trial SentiNot 20
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENTINOT_2
Brief Summary:
The trial aims to investigate the use of superparamagnetic iron oxide SPIO nanoparticles as a tracer for delayed sentinel lymph node dissection d-SLND in patients where upfront axillary surgery SLND is oncologically deemed unnecessary and should be avoided This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast DCIS an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy SPIO is injected in the primary operation and should final specimen pathology demonstrate invasive breast cancer only then is an operation in the axilla d-SLND performed
Detailed Description:
The SentiNot 20 protocol aims to elucidate the effectivity and accuracy of the delayed sentinel lymph node dissection concept dSLND when upfront SLND is considered unnecessary such as in the setting of a preoperative diagnosis of DCIS in cases of unclear BIRADS 4 or 5 lesions that are planned for diagnostic excisional biopsy or in selected cases of risk reducing mastectomy Acknowledging the large variance of practice in this setting the study aims to address pragmatism to allow for inclusion For this reason the trial is designed separately and independently for mastectomy and breast conserving surgery so that participating sites can recruit as fitting in their practice
In patients included in the SentiNot 20 trial SPIO MagTrace20 ml is injected up to 24 hours preoperatively or perioperatively during primary breast surgery on patients with a preoperative diagnosis of DCIS or suspicious lesions with no clear diagnosis of invasive cancer but considered for SLND The SPIO is injected close to the lesion If injected less than 24 hours before the operation a 5 minute massage should be performed Planned breast surgery is performed The transcutaneous magnetic counts by SentiMag in the axilla is measured at the end of the breast procedure so as to allow for confirmation that SLND may be identified Thusthe SLN is consequently marked with SPIO but not excised
In this manner women that have pure DCIS on final histopathological examination have avoided unnecessary upfront SLND
If there is underlying invasive breast cancer on final histopathological examination SLND will be performed at a second operation d-SLND A preoperative injection of radioisotope RI RI will be added to maximize the chance to detect the SLN SLND will start with a registration of the magnetic and isotope signal in the axilla and the incision will be placed in relation to the signal In patients that have undergone mastectomy tracers are to be injected intracutaneously in the lateral part of the mastectomy scar The routine use of blue dye BD is strongly advised but is not compulsory However if no transcutaneous signal for SPIO and RI is measured in the axilla pre-incision an injection of BD according local routines will be administered Subsequently SLND will be performed Patients with upgrade to invasive cancer will undergo SLND but will be randomized with an allocation ratio of 11 to SentiMag first or Radioactive probe first This will mandate the principal modality to perform SLND Every step of the procedure will be controlled if the principal modality fails then the surgeon will use the secondary If the principal modality succeeds the secondary will be registered and documented
The procedure will be divided to the following steps
Transcutaneous axillary signal detection
Subcutaneous axillary detection after the incision has been performed
In situ SLN identification
SLN retrieval ex vivo
Residual axillary signal Background counts If a SLND is successfully completed with the primary modality and no residual axillary signal is detected before completing the procedure the secondary modality will be undertaken to allow for the detection of discordance
Principle modalities maybe either RI or SPIO If BD is used dyed lymphatics should be ignored until failure with both modalities has been reached The success of each modality principal and secondary will be controlled per step If the surgeon documents principle modality failure for a given step this is to be documented The intention-to-treat principle will apply but if there is failure of the modality randomized as principle then the per-protocol-analysis principle will apply All SLNs magnetic brown radioactive blue will be removed Palpable nodes may be removed according to surgeon discretion but should be reported as such Total technique failure has to be discussed with the patient in advance and a plan with patient consent consisting of no-surgery sampling axillary dissection or treatment according to intraoperative decision has to be available If no SLN is found the procedure performed axillary clearance sampling etc should be discussed in advance with the patient The SLN may be sent for frozen section in order to avoid a third operation if SLN metastases are present
Standard of care patients SLND performed upfront for diagnoses included in the inclusion criteria or patients going to l-SLND without SPIO may also be enrolled in the study prospectively as a control armAdditionally patient preference will be tolerated and results will be reported for study secondary and other pre-specified endpoints Patients in the control group has to be informed that their un-identified data will be used as a comparison and an oral consent has to be given before surgery regardless whether SLND is planned or not This will allow for controlled real world data from a prospective control arm in fashion of a cohort
In patients included in the SentiNot 20 trial SPIO MagTrace20 ml is injected up to 24 hours preoperatively or perioperatively during primary breast surgery on patients with a preoperative diagnosis of DCIS or suspicious lesions with no clear diagnosis of invasive cancer but considered for SLND The SPIO is injected close to the lesion If injected less than 24 hours before the operation a 5 minute massage should be performed Planned breast surgery is performed The transcutaneous magnetic counts by SentiMag in the axilla is measured at the end of the breast procedure so as to allow for confirmation that SLND may be identified Thusthe SLN is consequently marked with SPIO but not excised
In this manner women that have pure DCIS on final histopathological examination have avoided unnecessary upfront SLND
If there is underlying invasive breast cancer on final histopathological examination SLND will be performed at a second operation d-SLND A preoperative injection of radioisotope RI RI will be added to maximize the chance to detect the SLN SLND will start with a registration of the magnetic and isotope signal in the axilla and the incision will be placed in relation to the signal In patients that have undergone mastectomy tracers are to be injected intracutaneously in the lateral part of the mastectomy scar The routine use of blue dye BD is strongly advised but is not compulsory However if no transcutaneous signal for SPIO and RI is measured in the axilla pre-incision an injection of BD according local routines will be administered Subsequently SLND will be performed Patients with upgrade to invasive cancer will undergo SLND but will be randomized with an allocation ratio of 11 to SentiMag first or Radioactive probe first This will mandate the principal modality to perform SLND Every step of the procedure will be controlled if the principal modality fails then the surgeon will use the secondary If the principal modality succeeds the secondary will be registered and documented
The procedure will be divided to the following steps
Transcutaneous axillary signal detection
Subcutaneous axillary detection after the incision has been performed
In situ SLN identification
SLN retrieval ex vivo
Residual axillary signal Background counts If a SLND is successfully completed with the primary modality and no residual axillary signal is detected before completing the procedure the secondary modality will be undertaken to allow for the detection of discordance
Principle modalities maybe either RI or SPIO If BD is used dyed lymphatics should be ignored until failure with both modalities has been reached The success of each modality principal and secondary will be controlled per step If the surgeon documents principle modality failure for a given step this is to be documented The intention-to-treat principle will apply but if there is failure of the modality randomized as principle then the per-protocol-analysis principle will apply All SLNs magnetic brown radioactive blue will be removed Palpable nodes may be removed according to surgeon discretion but should be reported as such Total technique failure has to be discussed with the patient in advance and a plan with patient consent consisting of no-surgery sampling axillary dissection or treatment according to intraoperative decision has to be available If no SLN is found the procedure performed axillary clearance sampling etc should be discussed in advance with the patient The SLN may be sent for frozen section in order to avoid a third operation if SLN metastases are present
Standard of care patients SLND performed upfront for diagnoses included in the inclusion criteria or patients going to l-SLND without SPIO may also be enrolled in the study prospectively as a control armAdditionally patient preference will be tolerated and results will be reported for study secondary and other pre-specified endpoints Patients in the control group has to be informed that their un-identified data will be used as a comparison and an oral consent has to be given before surgery regardless whether SLND is planned or not This will allow for controlled real world data from a prospective control arm in fashion of a cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None