This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Participants are indicated to receive LUMISIGHT as part of their breast cancer care. There is no investigational drug associated with this study. LUMISIGHT has a risk of serious hypersensitivity reaction, and this study seeks to further evaluate that risk.
The LumiSystem is the combination of FDA approved LUMISIGHT (pegulicianine) for injection (NDA 214511) and Lumicell Direct Visualization System (DVS) (PMA P230014). These products are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. This post market study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Additional study objectives are to evaluate the incidence of and characterize other severe hypersensitivity reactions. Study assessments include assessment of adverse events of interest (including laboratory data as indicated in this protocol), physical examination, and assessment of blood pressure, heart rate, and oxygen saturation before and after LUMISIGHT administration. Suspected cases of anaphylaxis and hypersensitivity reactions are adjudicated by a Clinical Endpoint Adjudication Committee according to a standard anaphylaxis definition and hypersensitivity grading system.
Study Type
OBSERVATIONAL
Enrollment
1,500
Incidence of adjudicated anaphylaxis
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Incidence of adjudicated serious hypersensitivity reactions
Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Incidence of hypersensitivity reactions
Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Distribution of severity of adjudicated hypersensitivity reactions
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated anaphylaxis.
Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated anaphylaxis among patients exposed to LUMISIGHT.
Time frame: 75 +/- 15 minutes of LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.
Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated severe hypersensitivity reaction (Grade ≥ 3) among patients exposed to LUMISIGHT.
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
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