MelanomaSCARLETTNCT05145829
Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients
A study testing Diagnostic Test: Sentinel node mapping using MRI in people with Melanoma, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Diagnostic Test: Sentinel node mapping using MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Sep 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 ≥18 years of age at the time of consent;
- Histological confirmed melanoma (patient must have primary cutaneous melanoma with Breslow thickness ≥ 0.8-2.0mm with or without ulceration or <0.8mm with ulceration (pT1b - pT2b, AJCC 8th edition));
- Indication for wide local excision (margin 1 cm) and SLN procedure;
- Patients should be willing and able to provide informed consent.
Who cannot join
- Intolerance/hypersensitivity to 99mTc-nanocolloid, PB, iron or dextran compounds;
- Iron overload disease;
- Pregnant or breast-feeding women;
- Previous surrounded lymph node surgery;
- Patients with head and neck melanomas;
- Standard MRI exclusion criteria;
Show all 11Show fewer
- Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
- Any other metal implants;
- Claustrophobia;
- MR-incompatible prosthetic heart valves;
- Patients who are unable or refuse to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medical Center
Sittard, Limburg, 6162BG
James van Bastelaar, MD, PhD, 0031884597777, j.vanbastelaar@zuyderland.nl
Loeki Aldenhoven, MSc, 0031884597777, l.aldenhoven@zuyderland.nl
About this study
Official title: Exploring an Alternative Pre-operative Sentinel Lymph Node Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients
Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.
The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients.
Read the detailed description
Rationale: Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.
Objective: The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients. A secondary objective is to assess the feasibility and diagnostic accuracy of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison with dual trace gold standard (99mTc and PB) in SLN procedures in melanoma patients.
Study design: A prospective single-arm feasibility study will be performed at the department of Surgical oncology at Zuyderland Medical Center Sittard, the Netherlands.
Study population: Adult patients (≥18 years) with primary melanoma stage I-II and an indication for wide local excision (1 cm) and SLN procedure will be included in the study.
Intervention (if applicable): All patients will undergo lymphatic mapping with a SPIO tracer (Magtrace®), 99mTc and PB.
Main study parameters/endpoints: The concordance in SLN detection rate (sensitivity and specificity) of SPIO/MRI and LS and SPECT/CT using 99mTc.
The concordance in SLN detection rate (sensitivity and specificity) of SPIO/magnetometer and the gold standard dual trace technique using 99mTc/Gamma probe and PB. Additionally, the number of post-injection (skin) reactions, complication and adverse events will be noted.
- Conditions
- Melanoma
- Being tested
- Diagnostic Test: Sentinel node mapping using MRI
- Keywords
- Magnetic tracer, Sentinel lymph node, Melanoma, MRI
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Sentinel node mapping using MRIDiagnostic test
Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI
| Study group | Role | What they receive |
|---|---|---|
| Melanoma patients | Experimental | All patients will undergo lymphatic mapping with SPIO, 99mTc and PB. Receives: Diagnostic Test: Diagnostic Test: Sentinel node mapping using MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. MRI image analyses will be performed by two independent professionals.
Measured: Before surgery (MRI scanning and scintigraphy)
Secondary outcomes (3)
The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe
The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals .
Measured: During SLNB (surgery)
Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI
Time/duration of 99mTc injection + LS + SPECT/CT and time/duration of SPIO injection + MRI will be compared
Measured: During SLNB (surgery)
Number of post-injection (skin) reactions, complication and adverse events
Descriptive only
Measured: At 10-14 days and at 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James van Bastelaar, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145829
- Sponsor's protocol ID
- METCZ20210156
- Acronym
- SCARLETT
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring an Alternative Pre-operative Sentinel Lymph Node Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients
- ClinicalTrials.gov ID
- NCT05145829
- Acronym / sponsor ID
- SCARLETT / METCZ20210156
- Conditions
- Melanoma
- Keywords
- Magnetic tracer, Sentinel lymph node, Melanoma, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 6 Dec 2021 (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.
Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.
The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients.
Detailed description
Rationale: Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.
Objective: The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients. A secondary objective is to assess the feasibility and diagnostic accuracy of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison with dual trace gold standard (99mTc and PB) in SLN procedures in melanoma patients.
Study design: A prospective single-arm feasibility study will be performed at the department of Surgical oncology at Zuyderland Medical Center Sittard, the Netherlands.
Study population: Adult patients (≥18 years) with primary melanoma stage I-II and an indication for wide local excision (1 cm) and SLN procedure will be included in the study.
Intervention (if applicable): All patients will undergo lymphatic mapping with a SPIO tracer (Magtrace®), 99mTc and PB.
Main study parameters/endpoints: The concordance in SLN detection rate (sensitivity and specificity) of SPIO/MRI and LS and SPECT/CT using 99mTc.
The concordance in SLN detection rate (sensitivity and specificity) of SPIO/magnetometer and the gold standard dual trace technique using 99mTc/Gamma probe and PB. Additionally, the number of post-injection (skin) reactions, complication and adverse events will be noted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma patients | Experimental | Diagnostic Test: Diagnostic Test: Sentinel node mapping using MRIAll patients will undergo lymphatic mapping with SPIO, 99mTc and PB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years of age at the time of consent;
- Histological confirmed melanoma (patient must have primary cutaneous melanoma with Breslow thickness ≥ 0.8-2.0mm with or without ulceration or <0.8mm with ulceration (pT1b - pT2b, AJCC 8th edition));
- Indication for wide local excision (margin 1 cm) and SLN procedure;
- Patients should be willing and able to provide informed consent.
Key exclusion criteria (11 listed)
- Intolerance/hypersensitivity to 99mTc-nanocolloid, PB, iron or dextran compounds;
- Iron overload disease;
- Pregnant or breast-feeding women;
- Previous surrounded lymph node surgery;
- Patients with head and neck melanomas;
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 |
|---|---|---|
| Diagnostic Test: Sentinel node mapping using MRISentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI | Diagnostic test | Melanoma patients |
Primary outcome
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN
Time frame: Before surgery (MRI scanning and scintigraphy)
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. MRI image analyses will be performed by two independent professionals.
3 secondary outcomes
The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe
Time frame: During SLNB (surgery)
Comparison between 99mTc injection + LS + SPECT/CT time vs SPIO injection + MRI
Time frame: During SLNB (surgery)
Number of post-injection (skin) reactions, complication and adverse events
Time frame: At 10-14 days and at 3 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: Sentinel node mapping using MRI in people with Melanoma, run by Zuyderland Medisch Centrum at 1 site 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 4 inclusion and 11 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 James van Bastelaar, MD, PhD (0884597777, j.vanbastelaar@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN (time frame: Before surgery (MRI scanning and scintigraphy)). 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 26 Jan 2023.