Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Patients who underwent sentinel lymph node biopsy with MagTrace one year ago.

Patients will undergo an MRI and mammography one year after MagTrace injections

Merel Spiekerman van Weezelenburg, MD

Yvonne Vissers, MD, PhD

Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts.

Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy.

Study design: Prospective trial in an outpatient clinic setting.

Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial.

Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023.

Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.

Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use

Size of the artefacts on MRI and mammography

The radiologist will score the assessability using a 4 point scoring system:

0. No artefact

1. Good diagnostic quality
2. Impaired but still readable
3. Hampered clinical assessment

Zuyderland Medisch Centrum

Principal investigator

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Micronutrients

All Drugs and Chemicals

Iron

Patients with the non-palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - the tumor lesion will be labeled with Magseed.

Patients with the palpable histologically confirmed breast cancer lesion that will undergo breast-conserving surgery and sentinel lymph node detection - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag.

Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy.

Patients with the non-palpable histologically confirmed breast cancer lesion - the tumor lesion will be labeled with Magseed and patient will undergo breast-conserving surgery and sentinel lymph node detection with Tc99.

Magseed

Patients with the palpable histologically confirmed breast cancer lesion - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. Patient will undergo sentinel lymph node detection with Tc99 and Sentimag localization system with breast surgery.

Magtrace

Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy, and later during target axillary dissection will be performed the biopsy of labeled lymph node during breast surgery.

Axillary lymph node metastasis - needle biopsy

Daniel Toman, MD

Otakar Kubala, MD,PhD

The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.

The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.

The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.

Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.

A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.

All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.

Patients receive the Magseed marker via ultrasound-guided injection into a lymph node or to non-palpable breast cancer lesion.

After completion of the study, patients are followed up within 6-30 days post-surgery at our surgical clinic.

Magseed and Magtrace Localization for Breast Cancer

Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System

Individual participant data will be made available to other researchers upon request.

Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis.

Descriptive statistics will be used to summarize surgeon rated ease of localization.

Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.

Descriptive statistics will be used to summarize transcutaneous detection rate.

Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.

University Hospital Ostrava

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Neoplasm Metastasis

Vulvar Neoplasms

Lymphatic Metastasis

Neoplastic Processes

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Patients will receive superficial and interstitial injection with a 23 G needle with of a total volume of 0.1 - 1 ml Magtrace at four sites in or near the tumor in vulva, the same localization as the injections of Technetium99m and Patent blue for tracing SLNs performed at the surgery. The injection is performed by one of the gynecologic cancer surgeons participating in this study.The time of migration of SPIO to the groin nodes is not known for vulvar cancer. Transportation by dynamic MRI, with selective sequences repeated during a time span of 1- 60 minutes after the injection.

Henrik Leonhardt

The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.

Sentinel lymph node (SLN) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (VSCC) in the absence of clinical signs of lymph node metastasis. The gold standard technique for identifying SLN utilizes Technetium (Tc99m) lymphoscintigraphy and blue dye. An alternative method has emerged using superparamagnetic iron-oxide (SPIO) and magnetic resonance imaging (MRI).

This study aims to enroll 20 VSCC patients scheduled for the SLN procedure. Determination of the minimal dosage of SPIO required to avoid excessive MRI artifacts while still identifying the SLN. Intraoperative SLN detection with a magnetometer will be compared with the gold standard gamma probe.

As secondary objective, in addition to determining the SNL, MRI analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.

MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer

Preoperative MRI and Magnetometer-guided Intraoperative Sentinel Lymph Node Detection With Superparamagnetic Iron Oxide Nanoparticles (SPIO) in Patients With Vulvar Cancer - a Feasibility Study (POSVUC Pilot)

The number of lymph nodes identified preoperatively with SPIO-enhanced MRI and intraoperatively with a magnetometer compared to Technetium-99m scintigraphy and blue dye.

Sahlgrenska University Hospital, Sweden

Principal Investigator

Clinically node negative before neoadjuvant chemotherapy

Clinically node positive before neoadjuvant chemotherapy

Sentinel lymph node tracer and metastatic lymph node clip

Fredrik AM Warnberg, prof

Kian AM Chin, MD

Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0

Uppsala University

Region Västmanland

University Hospital, Linkoeping

Baylor College of Medicine

The University of Hong Kong-Shenzhen Hospital

Royal Marsden NHS Foundation Trust

University of Athens

University College Dublin

Vastra Gotaland Region

professor

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

In case of a primary staging laparotomy the diagnosis of malignancy is based on a frozen section of the resected adnexa, followed by the sentinel node technique during the same procedure.

On the other hand, in some cases early stage EOC is only diagnosed after the primary surgery, when the surgeon resects the ovary with the suspicion of benign disease. If the adnexa are already removed before the diagnosis of malignancy, a secondary staging laparotomy is required and, in this case, a single step approach for SLN is not feasible.

In the proper ovarian ligament (or its remnants), close to the ovary and just below the peritoneum Magtrace® will be injected via a 12 Gauge (2mm) needle. This injection will be followed by an injection of 20 MBq 99mTc via the same 12 Gauge (2mm) needle.

If a hysterectomy has been conducted, this step can be omitted. In the infundibulopelvic ligament (suspensory ligament of the ovary), close to the ovary and just below the peritoneum Magtrace® will be injected via a 12 Gauge (2mm) needle. This injection will be followed by an injection of 20 MBq 99mTc via the same 12 Gauge (2mm) needle.

Pim Laven, Drs.

Sandrina Lambrechts, Dr.

Epithelial ovarian cancer (EOC) remains the tumour with the most unfavourable prognosis within the field of gynaecological oncology. The incidence of ovarian cancer in the Netherlands in 2008 was 14.5 per 100.000, with 12.3 deaths per 100.000. In the US in 2007 the incidence was 13.0 per 100.000 and there were 8.2 deaths per 100.000. The high mortality rate is partially due to the fact that approximately 75% of patients is diagnosed with advanced stage EOC. The remaining 25% of patients are diagnosed in an early stage, which require a complete surgical staging procedure including pelvic and para-aortic lymphadenectomy. Although this lymphadenectomy is standard-of-care, it leads to significant morbidity in these patients. Mainly direct postoperative complications such as infection, repeat surgery and early death have been reported. Also, long-term complications such as lymph cysts or lymphedema have been described.

A potential method to reduce this morbidity and mortality, as already been described in other cancers such as breast cancer and vulvar cancer, is utilizing a sentinel lymph node (SLN) technique. By identifying and resecting the SLN, the patient is potentially spared form lymphadenectomy.

Background EOC can metastasize through three different pathways: intraperitoneal (in the abdominal cavity), lymphogenous or haematogenous \[5,6\]. Concerning the lymphogenous spread, it is clear that lymphatic spread of EOC occurs mainly to the para-aortic lymph nodes. It is theorized that the tumour cells follow the lymph vessels that accompany the ovarian vessels in the infundibulopelvic ligament up to the upper para-aortic region and renal vein. Additionally, pelvic lymph node metastases are also frequently found. These tumour cells probably follow a different route, migrating via the para-uterine vessels in the broad ligament towards the uterine vessels and further on to the iliac vessels and lymph nodes. In some case reports, isolated inguinal node metastases are also described. The exact mechanism of this route of metastasis is still unclear, but the metastatic cells might follow the course of the round ligament towards the inguinal lymph nodes or follow the iliac vessels towards the femoral vessels.

According to the International Federation of Gynaecology and Obstetrics (FIGO), EOC with lymph node metastases is classified as FIGO stage IIIA1. This significant upstaging is reflected in the need for adjuvant treatment. While patients with cancer confined to the ovaries (FIGO stage I) do not require adjuvant chemotherapy, patients with EOC FIGO stage III require additional treatment. Therefore, the detection of lymph node metastases is of utmost importance in perceived early stage disease.

In case of a clinical early stage ovarian cancer, standard-of-care is a staging laparotomy including bilateral pelvic and para-aortal lymphadenectomy. There is 14% (range 6.1-29.6%) chance of finding lymph node metastases . The incidence is higher in the grade 3 tumours (20.0%) and the serous histological subtype (23.3%). Whereas in grade 1 and mucinous tumours this is respectively 4.0% and 2.6%. By removing a greater number of lymph nodes, the detection rate for metastases rises . Although complete pelvic and para-aortic lymphadenectomy is standard-of-care, radical lymphadenectomy has been associated with serious morbidity and this is a major reason for the difference in the extent of lymph node dissection between centres.

By resecting only the SLN, significant reduction of morbidity and mortality can be obtained in comparison with the standard-of-care. SLN surgery is based on the concept that, if the SLN has no malignant cells, the likelihood that other lymph nodes are affected is reduces to almost non-existent. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity and potential mortality. The SLN technique has been proven to be effective in other cancers such as breast cancer and malignant melanoma. In the gynaecological field it has been shown to be effective in vulvar cancer. Several SLN studies have been conducted in patients with ovarian cancer with promising results, as summarized in Table 1.

Rationale As stated, the goal of utilizing SLN in early-stage EOC surgery is to reduce patient morbidity while obtaining optimal oncological outcomes. By resecting only the SLN, the patients would be spared from radical lymphadenectomy, reducing short and long-term complications.

As summarized in Table 1, most studies utilize 99mTc and blue dye to visualize the SLN. Although detection rates are good with these techniques, they have major disadvantages. 99mTC is an isotope, as such it exposed the patient to an irradiation dose. Although total dosage is limited, eliminating isotopes in surgery would reduce the potential harm for the patient and the medical staff during surgery. Furthermore, the process to produce and administer 99mTC is a costly and resource-intensive procedure, requiring the cooperation of nuclear medicine, radio-pharmacy and logistics. As such, reducing the need for 99mTc would benefit the patient, medical staff and the healthcare system in general by reducing costs. Blue dye such as Patent Blue is often used for the detection of SLN. However, it also has major disadvantages. Firstly, it potentially occludes the entire operation field because of dissemination of the dye further than the SLN. Without optimal visualisation of the anatomy, the surgeon can expect more difficult dissection. Secondary, blue dye can cause a severe allergic reaction, leading to anaphylactic shock in up to 2% of patients.

Magtrace® is a brownish ferromagnetic substance capable of identifying the SLN. This novel technique has already been extensively researched in breast cancer and proven to be non-inferior to 99mTc with blue dye. These promising results led to licensing in the European Union. In this trial, the investigators wish to examine the potential of this technique in EOC, eliminating the disadvantages of 99mTc and blue dye. However, this is still a pilot study with unknown efficacy in EOC. Therefore, in order to minimize potential harm to the patient, 99mTc will be co administrated. This has been deliberately chosen due to the extensive literature concerning this sentinel mapping technique (see Table 1). If the efficacy of Magtrace would prove successful, the ultimate goal is to omit 99mTc in further studies and use Magtrace® only to identify the SLN.

In this pilot study, researchers will include two study arms. One in primary staging laparotomy, the other one in secondary staging laparotomy. The rationale of these two arms is based on the clinical practice, were surgeons not always suspect malignancy before resection of the adnexa. In case of a primary staging laparotomy the diagnosis of malignancy is based on a frozen section of the resected adnexa, followed by the sentinel node technique during the same procedure. On the other hand, in some cases early stage EOC is only diagnosed after the primary surgery, when the surgeon resects the ovary with the suspicion of benign disease. If the adnexa are already removed before the diagnosis of malignancy, a secondary staging laparotomy is required and, in this case, a single step approach for SLN is not feasible. The design of two study arms in this pilot study allows to compare the efficacy of Magtrace in native tissue (primary staging laparotomy) with tissue afflicted by previous surgery (secondary staging laparotomy).

Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer

Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer: a Pilot Study

Can sentinel lymph nodes be found using magtrace this means a positive signal. The patient will have a interpatient control using radio active technetium. Outcome will be reported as: Magtrace found sentinel lymph node: yes or no

Between 1 primary staging laparotomy and 2 in secondary staging laparotomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use	NCT05637528	Breast Cancer	MRI	18 Years -	Zuyderland Medisch Centrum
Magseed and Magtrace Localization for Breast Cancer	NCT05161507	Breast Carcinom... Breast Carcinom...	Magseed Magtrace Axillary lymph ...	18 Years -	University Hospital Ostrava
MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer	NCT06273501	Vulvar Cancer Lymph Node Meta...	Magtrace	18 Years -	Sahlgrenska University Hospital, Sweden
MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer	NCT06273501	Vulvar Cancer Lymph Node Meta...	Magtrace	18 Years -	Sahlgrenska University Hospital, Sweden
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy	NCT06104371	Breast Cancer	Magtrace	18 Years - 85 Years	Vastra Gotaland Region
Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer	NCT05375526	Ovarian Cancer Lymph Node Meta...	Magtrace	18 Years - 85 Years	Maastricht University Medical Center
Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use	NCT05637528	Breast Cancer	MRI	18 Years -	Zuyderland Medisch Centrum

Spots Global Cancer Trial Database for magtrace

Every month we try and update this database with for magtrace 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 magtrace

Every month we try and update this database with for magtrace 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 magtrace 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.