Malignant Melanoma Clinical Trial
— LIMITOfficial 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
Verified date | December 2022 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | October 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Malignant melanoma patients having one of the following characteristics: - Breslow score = 1 mm - Breslow score = 0.7 mm associated with ulceration - Breslow score = 0.7 mm associated with regression - Breslow score = 0.7 mm associated with Clark Level IV / V - Breslow score = 0.7 mm associated with mitotic rate = 1/mm2 in young patients - Merkel cell carcinoma Exclusion Criteria: - Age < 18 years - Pregnancy and breastfeeding (pregnancy test to be performed for women of child-bearing potential, defined as women who are not surgically sterilized/ hysterectomized, and/or who are postmenopausal for less than 12 months) - Known allergy to ICG or Iodine - Previous chemotherapy, radiotherapy or surgery to the lymph nodes of interest - Lack of capacity to provide informed consent - Current enrolment in any other interventional study |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital, University Hospital Bern, University of Bern | Bern | Kanton Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging. | To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS. | one hour | |
Secondary | Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging in specific anatomical locations and in defined patient groups (e.g. groups defined based on BMI, sex, age). | The study seeks primarily to determine ability of the VisionSense NIRFI technology to transcutaneously identify SLNs as effectively as LS. | one hour |
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