Melanoma (Skin)MelaDiffNCT05569707
MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients
A study testing Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag in people with Melanoma (Skin), run by University of Twente at 2 sites in Netherlands.
Trial summary
The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with melanoma of the upper or lower extremities scheduled for SLNB;
- Willing to \& able to write informed consent from the subject prior to participation;
- Willing to \& capable of following study procedures;
- Is older than 18 years;
- Speaks and understand the Dutch language
Who cannot join
- Intolerance / hypersensitivity to iron or dextran compounds
- Pregnant or lactating patients;
- Patients having a pacemaker.
- Patients non eligible for MRI investigation (pacemakers or other implantable devices in the chest wall and/or lower body, claustrophobic, etc.)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Spectrum Twente
Enschede
Anneriet Dassen
Ziekenhuisgroep Twente (ZGT)
Hengelo
Daniëlle de Leeuw
About this study
Official title: MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients Measured With DiffMag
The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient.
To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time.
Read more
A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD\&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status.
In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.
- Conditions
- Melanoma (Skin)
- Being tested
- Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag
- Keywords
- Magnetic sentinel lymph node biopsy (SLNB), Lymph node detection, Lymph node staging, MR lymphography, Super paramagnetic iron-oxide (SPIO) nanoparticles
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMagDevice
In addition to the standard procedure, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with SPIO particles (Magtrace®).
| Study group | Role | What they receive |
|---|---|---|
| MelaDiff | Other | Patients with melanoma of the extremities included in the protocol. Preoperative, patients will receive two MRI-scans and a magnetic tracer injection at the primary tumor site. During surgery, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with Magtrace®, in addition to the standard procedure. Receives: Device: Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag |
What is being measured
The primary outcome is the main question the study is designed to answer.
True positive/False negative rate for a magnetic SLN detection measured by DiffMag system compared to radioactive detection.
Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer DiffMag.
Measured: through study completion, an average of 1 year
True positive/False negative rate for a magnetic SLN detection measured by Sentimag system compared to radioactive detection.
Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer Sentimag.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
True positive/False negative rate for metastatic SLN using ex vivo MRI
Determining the feasibility of LN mapping with preoperative SPIO-enhanced MR lymphography and examining the use of SPIO-enhanced MR lymphography for LN staging.
Measured: through study completion, an average of 1 year
True positive/False negative rate for metastatic SLN using in vivo MRI
Determining the feasibility of LN mapping with preoperative SPIO-enhanced MR lymphography and examining the use of SPIO-enhanced MR lymphography for LN staging.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anke Christenhusz, University of Twente
- Investigators
- Lejla Alic, PhD, Study chair, University of TwenteAnneriet Dassen, PhD, Principal investigator, Medisch Spectrum Twente Enschede
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569707
- Sponsor's protocol ID
- NL79537.100.21
- Acronym
- MelaDiff
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients Measured With DiffMag
- ClinicalTrials.gov ID
- NCT05569707
- Acronym / sponsor ID
- MelaDiff / NL79537.100.21
- Conditions
- Melanoma (Skin)
- Keywords
- Magnetic sentinel lymph node biopsy (SLNB), Lymph node detection, Lymph node staging, MR lymphography, Super paramagnetic iron-oxide (SPIO) nanoparticles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient.
To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time.
A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD\&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status.
In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MelaDiff | Other | Device: Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMagPatients with melanoma of the extremities included in the protocol. Preoperative, patients will receive two MRI-scans and a magnetic tracer injection at the primary tumor site. During surgery, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with Magtrace®, in addition to the standard procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with melanoma of the upper or lower extremities scheduled for SLNB;
- Willing to \& able to write informed consent from the subject prior to participation;
- Willing to \& capable of following study procedures;
- Is older than 18 years;
- Speaks and understand the Dutch language
Key exclusion criteria (4 listed)
- Intolerance / hypersensitivity to iron or dextran compounds
- Pregnant or lactating patients;
- Patients having a pacemaker.
- Patients non eligible for MRI investigation (pacemakers or other implantable devices in the chest wall and/or lower body, claustrophobic, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMagIn addition to the standard procedure, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with SPIO particles (Magtrace®). | Device | MelaDiff |
Primary outcome
True positive/False negative rate for a magnetic SLN detection measured by DiffMag system compared to radioactive detection.
Time frame: through study completion, an average of 1 year
Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer DiffMag.
True positive/False negative rate for a magnetic SLN detection measured by Sentimag system compared to radioactive detection.
Time frame: through study completion, an average of 1 year
Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer Sentimag.
2 secondary outcomes
True positive/False negative rate for metastatic SLN using ex vivo MRI
Time frame: through study completion, an average of 1 year
True positive/False negative rate for metastatic SLN using in vivo MRI
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lejla Alic, PhD study chair
University of Twente
Anneriet Dassen, PhD principal investigator
Medisch Spectrum Twente Enschede
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag in people with Melanoma (Skin), run by University of Twente at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke Christenhusz, MSc (+3153 489 1592, a.christenhusz@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True positive/False negative rate for a magnetic SLN detection measured by DiffMag system compared to radioactive detection. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.