Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

All Drugs and Chemicals

Iron

All patients will receive Radioisotope according to standard of care. They will also receive SPIO in a timeframe of clinical convenience, depending on whether primary response is planned by means of MRI. For patients that are ycN0, SLND or TAD will be performed. For those that convert from cN1 to ycN0, the index lymph node will be marked with a paramagnetic marker. Axillary surgery will be undertaken with the magnetic technique and each retrieved lymph node will be controlled for radiation. Upon the completion of the procedure, a background control will be performed with the radioactive signal as guide, to ensure standard of care best practice. Any palpable lymph nodes that are not sentinels with either tracer may be removed at surgeon discretion but will be reported seperately.

SLND or TAD by the magnetic technique (SPIO)

Andreas U Karakatsanis, MD, PhD

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration.

For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST.

The main points to investigate are:

1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
2. If the nodal yield and the accuracy of the procedure are affected

Superparamagnetic Iron Nanoparticles (SPIO) have shown comparable performance to the standard of Radioisotope (RI) +/- blue dye (BD) for Sentinel Lymph Node Detection in breast cancer, with the advantage of clinical convenience due to easier accessibility, disposal and injection days before surgery.

More interestingly, SPIO provides the possibility for delayed SLND in the setting of a preoperative diagnosis of DCIS, enabling SLN detection weeks after breast surgery, only when specimen pathology has demonstrated invasive cancer, as shown in the SentiNot study. The role of SPIO for SLND in the setting of primary systemic therapy (PST) has not been extensively investigated, while the timeframe from SPIO administration to successful SLN detection in a similar fashion to SentiNot, but in the setting of PST has yet to been defined.

Current evidence suggest that RI-based SLN detection is the accepted standard following PST, with RI-based dual mapping specifically recommended in cN+-to-ycN0 patients, when SLND or targeted axillary dissection (TAD) are performed, as the number of SLNs retrieved has been inversely linked to the false negative rate of the procedure.

Apart from the logistic benefits of SPIO administration prior to PST, an aspect of potential interest is the ability to map the axilla, before the fibrotic changes induced by chemotherapy and lymphatic remodelling occur, that are a concern, especially in the node-positive patients at presentation.

However, in this case, it is imperative to investigate that SPIO remains detectable after a prolonged period of administration and that it does not migrate to higher nodal echelons. While preliminary data suggested feasibility, the aim of this dedicated study was to investigate the width of timeframe of SPIO administration in patients undergoing PST and how SPIO-based detection and concordance to the RI are affected.

In this study, patients scheduled for SLND or TAD after surgery will undergo the procedure with RI as the standard of care and will moreover receive SPIO. The administration of SPIO will take place either on the preoperative period but after the completion of PST, or before the induction of PST. The reason for this is to create a wide time-frame to allow for conclusion with regards to whether the mapping of the axilla prior PST by SPIO is a feasible technique that will then be addressed in a dedicated trial.

Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

A Feasibility Study on the Timeframe of Superparamagnetic Iron Oxide Nanoparticles Administration in Patients Receiving Primary Systemic Therapy for Early Breast Cancer

Patients have not been consented for IPD and separate consent should be sought for this. For any interest, contact andreas.karakatsanis@uu.se

The successful retrieval of at least two and at least three SLN detected by each tracer (SPIO or radioisotope) separately.

Any adverse events reported in relation to SPIO administration

This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.

The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.

The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)

The median number of SLNs retrieved with each tracer

The rate (SLNs detected by both tracers/SLNs detected by the radioisotope)

Uppsala University Hospital

Uppsala University

Associate Professor, MD, PhD

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients scheduled to have their sentinel lymph nodes removed, as part of standard of care.

Brian Slomovitz, MD

The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement.

The investigators also hypothesize that SLND is an effective method of staging these patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with newly diagnosed EC and this prognostic information obtained from SLND could guide selection of adjuvant treatment and improve overall survival.

Using SLND as an alternative to lymphadenectomy may also have additional medical and economic impacts, such as, decreasing prolonged hospitalization and associated costs by shortening overall surgery duration.

This is a non-interventional prospective chart review evaluating the clinical utility of SLND for detecting nodal metastasis of early stage endometrial cancer through data collection.

Patients who are scheduled to undergo standard-of-care (SOC) surgical staging for EC (sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)) (pelvic and paraaortic lymphadenectomy may (or may not) also be performed in addition to SLND) will be approached for consent. After these patients have completed the above SOC surgical procedures, research staff will review and collect data from their medical charts. For the subset of these patients who are found, during their SOC surgery, to have positive nodes, research staff will continue to review and collect data from their medical charts after their standard of care follow-up visits with their oncologist

All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed; that is, all patients enrolled on this trial were consented by the research team because they were already scheduled to undergo sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)). As part of this same SOC surgery, some of these patients also may have undergone pelvic and paraaortic lymphadenectomy in addition to SLND.

Within the research database built for this study, patients will be classified into risk strata (either low or high risk EC) as per the Modified Mayo Criteria. This classification will be partly based on the SOC post-surgical International Federation of Gynecology and Obstetrics (FIGO) staging. To establish progression-free survival (PFS) and overall survival (OS), research staff will intermittently perform medical chart reviews for only those patients with nodal metastasis for a minimum of 2 years (maximum of 6 years).

Due to the nature of the disease under investigation, only women are eligible to participate in this trial. Women of all races and ethnicities may participate in this research study.

Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer

The Validity of Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer (EC)

The rate of SLND positivity rate overall and by risk group in patients with clinically apparent early-stage EC. EC patients will be classified as high or low risk group based on the modified Mayo Criteria (Mariani A 2008, Milam 2012).

The rate of the negative predictive value (NPV) and its complement the false negative predictive value (FNPV) rate of the SLND procedure in the subset of patients who also undergo partial or full lymphadenectomy. Negative Predictive Value (NPV) will be calculated by dividing the number of true negatives by the total number of patients with a negative SLN (false negatives and true negatives. False Negative Predictive Value (FNPV) rate will be calculated as the number false negatives divided by all patients without nodal metastasis (the number of false negatives and true negatives). FNPV rate is also known as the False Omission Rate (FOR); FNPV is the complement of NPV.

Proportion of type(s) of lymph node metastases (isolated tumor cells (ITC), micrometastases, or macrometastases) described by SLND in true positive (TP) and false negative (FN) patients. True positives (TPs) are those patients with positive SLN who also have nodal metastasis. False negatives (FNs) are those patients with negative SLN who have nodal metastasis.

The investigators will compare nodal positivity rates using sentinel lymph node biopsies, and the pathologic protocol for sentinel lymph node biopsies. Positivity rates will be correlated to traditional pathologic factors, including grade, depth of invasion, lymphovascular space invasion, cervical involvement, and histology. Once this information is collected, the investigators will try to assess rates of sentinel lymph node positivity, and its association with these factors.

The rate of progression-free survival (PFS) in patients with nodal metastasis. Progression-Free Survival is defined as the length of time from the date of first dose of study treatment until date of disease progression or death due to any cause, whichever comes first.

The rate of overall survival (OS) in patients with nodal metastasis. Overall survival is defined as the length of time from either the date of first dose of study treatment until death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment	NCT05985551	Breast Cancer Chemotherapy Ef... Sentinel Lymph ...	SLND or TAD by ...	18 Years -	Uppsala University
Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer	NCT02834988	Endometrial Can...		18 Years -	University of Miami

Spots Global Cancer Trial Database for slnd

Every month we try and update this database with for slnd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for slnd

Every month we try and update this database with for slnd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for slnd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.