Here is the design of a 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

Included conditions:
- Malignant Melanoma
- Merkel Cell Carcinoma

Study Armgroups:
- {'label': 'Comparison result lymphoscintigraphy with ICG lymphography', 'type': 'EXPERIMENTAL', 'description': 'The patient first receives a standard Tc-99m-based lymphoscintigraphy. The identified lymph nodes are not marked in the patients, so that the surgeons are not affected in lymph node identification during ICG and near infrared fluorescence imaging. The surgeon also has no access to lymphoscintigraphy images.\n\nTranscutaneous ICG lymphography is then performed by intradermal injection of ICG around the scar of the primary tumor excision and transcutaneous fluorescence evaluation with the Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD) and results are compared.', 'interventionNames': ['Diagnostic Test: Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)']}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)', 'description': 'Injection of ICG intradermally around the scar of the primary excision of the tumour and transcutaneous assessment of fluorescence with the VS3-3DHD camera (Visionsense™ VS3 - Stereoscopic High Definition Visualisation System ).', 'armGroupLabels': ['Comparison result lymphoscintigraphy with ICG lymphography'], 'otherNames': ['Indocyanin green (ICG)']}

Primary Outcomes:
- {'measure': 'Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.', 'description': 'To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.', 'timeFrame': 'one hour'}

Please estimate the sample size based on the assumption: 
95% confidence interval with a maximum clinically acceptable width of 10% (50%-70%).
2.8
        Statistical analysis and sample size calculation
        The statistical analysis will be performed by a statistician at the end of the study (ie, when all patients are included). Baseline characteristics will be reported as mean and standard deviation or median and interquartile range, and number and percentage of patients for continuous and categorical variables, respectively.
        The sensitivity (ie, the proportion of NIRFI and LS positive LN among LS positive LN) will be reported with a 95% confidence interval (CI) and adjusted for multiple observations per patients using generalized estimating equations[19] or the method by Rao and Scott.[20] The number of LS-negative LNs that are NIRFI positive will be reported.
        Data relating to the ability of SLNs to be successfully identified transcutaneously by NIRFI will be grouped anatomically and according to patientsâ characteristics (eg, BMI, sex, and age) and afterward analyzed to determine if certain anatomical regions or patient groups have different sensitivity rates.
        Only patients with positively identified LNs in LS will be included in the study and there will be no missing data from the LS. We do not expect any or only a small number of missing NIRFI data. However, patients with missing data in NIRFI will be excluded from the main analysis. For a sensitivity analysis, we will assume that all missing NIRFI results will be negative. The number of missing data will be reported together with the reasons behind their absence.
        All of the patients will have at least 1 positive LN in LS, but there could also be cases with more than 1 LN per patient, increasing the precision of the sensitivity estimate. As it is not possible to make a reasonable assumption about the number of LNs per patient and the correlations of the measurements within a patient, we will recruit 93 patients. Sample size at the required absolute precision level for sensitivity was calculated with Buderer formula.[19,20] We assumed a sensitivity of 60% (based on Namikawa et al â identification rate with ICG of 63.4% before skin incision[16]) and a maximum clinically acceptable width of the 95% CI of 10% (ie, 50%â70%), for a total of 93 LNs identified by LS.