Hypersensitivity Reactions
Conditions
Keywords
Lumicell, LumiSystem, LUMISIGHT, Breast Cancer, Intraoperative margin detection, anaphylaxis, hypersensitivity, drug allergy, post-market safety, fluorescence guided surgery
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Lumicell, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure * Indicated to receive LUMISIGHT at a dose of 1 mg/kg * Willing and able to comply with the study procedures
Exclusion criteria
* History of hypersensitivity reactions to pegulicianine. * Inability to comply with the requirements of the protocol. * Treating physician does not think it is in the best interest of the patient to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adjudicated anaphylaxis | 75 +/- 15 minutes post LUMISIGHT injection | Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adjudicated serious hypersensitivity reactions | 75 +/- 15 minutes post LUMISIGHT injection | Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT. |
| Incidence of hypersensitivity reactions | 75 +/- 15 minutes post LUMISIGHT injection | Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT. |
| Distribution of severity of adjudicated hypersensitivity reactions | 75 +/- 15 minutes post LUMISIGHT injection | Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions. |
| Descriptive statistics of population with occurrence of adjudicated anaphylaxis. | 75 +/- 15 minutes of LUMISIGHT injection | 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. |
| Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions. | 75 +/- 15 minutes post LUMISIGHT injection | 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. |
Contacts
CONTACTVP, Clinical Affairs and Pharmacovigilance
CONTACTSenior Clinical Trial Manager
PRINCIPAL_INVESTIGATORJorge Ferrer, PhD
Lumicell, Inc.
Outcome results
None listed