Melanoma StageIMINEMNCT03449615
Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
An observational study of Melanoma Stage and Sentinel Lymph Node, run by Sociedad Española de Oncología Quirúrgica at 1 site in Spain.
Trial summary
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage, Sentinel Lymph Node
- How many people
- 186 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2015to Sep 2018
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.
Who may be able to join
- Adult patients (>18 years of age),
- with diagnosis of cutaneous melanoma and
- in which SLNB is indicated as a staging method, and
- with cN0 result after clinical-echographic-cytohistological evaluation.
Who cannot join
- Previous treatment with systemic therapy.
- Recent previous surgery (<3 months) in the area susceptible of lymphatic drainage from the melanoma.
- Intolerance or hypersensitivity to iron or dextran compounds.
- Impossibility of use of radioisotope.
- Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin).
- Implantation of pacemakers or partially or totally metallic thoracic implants.
- Treatment with iron chelators (deferasirox, deferoxamine, ...).
Trial locations and contacts
1 site in 1 country.
Antonio Piñero Madrona, MD PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario "Virgen de la Arrixaca"
Murcia, 30120
Antonio Piñero Madrona, MD PhD, pineromadrona@gmail.com
Antonio Piñero Madrona, MD PhD
About this study
Official title: Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.
Read the detailed description
- Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
- Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
- Optional: colorant injection in standard form. Local massage of 5-10 minutes.
- After 20 minutes: transcutaneous measurement with SentiMag®
- Valuing territories (lymphoscintigraphy information?)
- Surgical identification measures:
- st with SentiMag®
- nd with gamma detection probe
- Ex vivo check and HRD record
- Conditions
- Melanoma Stage, Sentinel Lymph Node
- Keywords
- Cutaneous melanoma, Sentinel node biopsy
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
SN detection
Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria.
Measured: During surgery
Secondary outcomes (1)
SN agreement
Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start21 Dec 2015
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma StageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Oncología Quirúrgica
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex España
- Responsible party
- Principal investigator, Antonio Piñero-Madrona, Sociedad Española de Oncología Quirúrgica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449615
- Sponsor's protocol ID
- SEOQ-MEL001
- Acronym
- IMINEM
- Status last verified
- Feb 2018
- First submitted
- 17 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
- ClinicalTrials.gov ID
- NCT03449615
- Acronym / sponsor ID
- IMINEM / SEOQ-MEL001
- Conditions
- Melanoma Stage, Sentinel Lymph Node
- Keywords
- Cutaneous melanoma, Sentinel node biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Sociedad Española de Oncología QuirúrgicaUniversity, hospital or other
- Collaborators
- Sysmex España
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 28 Feb 2018 (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.
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.
Detailed description
- Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
- Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
- Optional: colorant injection in standard form. Local massage of 5-10 minutes.
- After 20 minutes: transcutaneous measurement with SentiMag®
- Valuing territories (lymphoscintigraphy information?)
- Surgical identification measures:
- st with SentiMag®
- nd with gamma detection probe
- Ex vivo check and HRD record
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.
Key inclusion criteria (4 listed)
- Adult patients (>18 years of age),
- with diagnosis of cutaneous melanoma and
- in which SLNB is indicated as a staging method, and
- with cN0 result after clinical-echographic-cytohistological evaluation.
Key exclusion criteria (7 listed)
- Previous treatment with systemic therapy.
- Recent previous surgery (<3 months) in the area susceptible of lymphatic drainage from the melanoma.
- Intolerance or hypersensitivity to iron or dextran compounds.
- Impossibility of use of radioisotope.
- Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SN detection
Time frame: During surgery
Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria.
1 secondary outcome
SN agreement
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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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.
Antonio Piñero Madrona, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Stage and Sentinel Lymph Node, run by Sociedad Española de Oncología Quirúrgica at 1 site in Spain.
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 7 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 1 Mar 2018. 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 Spain. 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 Antonio Piñero Madrona, MD PhD (pineromadrona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SN detection (time frame: During surgery). 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 1 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.