Validation of Ferromagnetic Tracer in Melanoma Sentinel Node (IMINEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03449615|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 1, 2018
|Condition or disease|
|Melanoma Stage Sentinel Lymph Node|
- 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 Type :||Observational|
|Estimated Enrollment :||186 participants|
|Official Title:||Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma|
|Actual Study Start Date :||December 21, 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||September 2018|
- 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.
- SN agreement [ Time Frame: During surgery ]Agreement in isotopic and ferromagnetic sentinel node identification. Measurement criteria will be coincidence in the same node (or nodes).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449615
|Contact: Antonio Piñero Madrona, MD PhDfirstname.lastname@example.org|
|Hospital Clínico Universitario "Virgen de la Arrixaca"||Recruiting|
|Murcia, Spain, 30120|
|Contact: Antonio Piñero Madrona, MD PhD email@example.com|
|Principal Investigator: Antonio Piñero Madrona, MD PhD|
|Principal Investigator: Jacobo Cabañas, MD PhD|
|Principal Investigator: Antonio R Rull, MD PhD|
|Principal Investigator: Roberto Rodriguez, MD PhD|
|Principal Investigator: Jesús Hernández Gil, MD PhD|