Malignant Melanoma Clinical Trial
Official title:
A Diagnostic Sensitivity Study Comparing Intradermal ICG and NIRFI With Intradermal Technetium 99m and Traditional Lymphoscintigraphy for Transcutaneous Identification of Sentinel Lymph Nodes in Malignant Melanoma
A diagnostic sensitivity study comparing intradermal indocyanine green (ICG) and near infrared fluorescence imaging (NIRFI) with intradermal technetium 99m and traditional lymphoscintigraphy (LS) for transcutaneous identification of sentinel lymph nodes (SLN) in malignant melanoma - a prospective Phase II clinical study in a single center.
Switzerland has the highest rate of new melanomas in Europe (19.2 per 100,000). Melanomas have the worst prognosis of all skin cancers. The current treatment depends on the histological diagnosis after a biopsy and is primarily related to the tumor thickness (Breslow Score), the tumor cells in division (mitosis rate), the substance defect of the skin (ulceration), the occurrence of regression, and the age of the patients. The initial treatment is performed by surgical removal with a safety margin of macroscopically healthy skin around the tumor. If the tumor thickness is more than 1 mm or more than 0.7 mm associated with a high mitosis rate in younger patients, ulcerations, regression or Clark Level IV / V, then current melanoma guidelines suggest that the patient undergoes sentinel lymph node biopsy (SLKB) as this is most likely the first site where metastases spread. Merkel cell carcinoma is a very aggressive, neuroendocrine skin tumor with a mortality rate of about 33% after 3 years. Due to the frequent lymphatic metastases, SLNB is highly recommended in all patients in order to better assess their prognosis. The gold standard technique to identify SLKs is to inject the radioisotope Technetium-99m around the primary tumor into the skin. The patient is then scanned to determine the position of the SLK after approximately 30 and 120 minutes. Other teams have attempted to identify transcutaneous SLK with ICG and NIRFI, but have concluded that ICG fluorescence technique is not reliable in patients with high BMI or a primary tumor with lymph drainage in the axillary lymph node region. This study aims to evaluate a medical device that uses an improved technology compared to previous studies (stereoscopic 3D high definition for both fluorescence and visible light imaging). The investigators hope is that by applying similar principles SLKs can be identified through the use of transcutaneous fluorescent dye injections and NIRFI. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04229277 -
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
|
N/A | |
Completed |
NCT03653819 -
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
|
N/A | |
Active, not recruiting |
NCT04074096 -
Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
|
Phase 2 | |
Completed |
NCT02935790 -
Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab
|
Phase 1 | |
Recruiting |
NCT05478876 -
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
|
N/A | |
Completed |
NCT01211262 -
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
|
Phase 1 | |
Recruiting |
NCT03649529 -
Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy
|
Early Phase 1 | |
Completed |
NCT03278665 -
4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
|
Phase 1/Phase 2 | |
Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT01455259 -
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00978913 -
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
|
Phase 1 | |
Completed |
NCT00232726 -
Clinical Study of Previously Untreated Patients With Malignant Melanoma
|
Phase 2 | |
Completed |
NCT00350597 -
GM-CSF as Adjuvant Therapy of Melanoma
|
Phase 2 | |
Completed |
NCT00336986 -
Efficacy Study of IL-21 to Treat Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT02523313 -
Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED
|
Phase 2 | |
Completed |
NCT04253574 -
Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
|
||
Completed |
NCT00179608 -
Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
|
Phase 1 | |
Terminated |
NCT00104884 -
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
|
Phase 2 | |
Recruiting |
NCT04593485 -
Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract
|
Phase 2 |