Invasive Breast Cancer Clinical Trial
Official title:
Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects with at least 1 lesion of tumor of the breast - Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Subjects who have been treated with radiation therapy on the chest. - Has had previous sentinel lymph node biopsy - Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard. | Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs. | At the end of the procedure, about 50 minutes | |
Secondary | Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems. | A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the participant. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve. | At the end of the procedure, about 50 minutes | |
Secondary | Number of samples with ICG detected in biopsy tissue | Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy. | At the end of the procedure, about 50 minutes | |
Secondary | Number of samples with lymph node detected in biopsy tissue | Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy. | At the end of the procedure, about 50 minutes | |
Secondary | Fluorescence intensity | Fluorescence intensity will be compared for the removed lymph nodes between the Smart Goggles and the standard used fluorescent imaging technology. Intensity will be reported in Arbitrary units
ยท |
Typically no more than 30 minutes | |
Secondary | Number of removed lymph nodes with cancer cells | Standard histological analyses will be performed on the biopsy specimens. Presence of absence of cancer cells in the removed lymph nodes will serve as the source of specificity. | At the end of the procedure, about 50 minutes | |
Secondary | Sensitivity as measured via the ICG accumulation curve | The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative sensitivity of the Smart Goggles for ICG detection in vivo. | At the end of the procedure, about 50 minutes | |
Secondary | Specificity as measured via the ICG accumulation curve | The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative specificity of the Smart Goggles for ICG detection in vivo. | At the end of the procedure, about 50 minutes | |
Secondary | Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras | Surgeons preference for using the Googles for ICG detection versus the current near-infrared NIR cameras | At the end of the procedure, about 50 minutes |
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