Post-market Safety Study of LUMISIGHT
ConditionHypersensitivity Reactions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLumicell, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
The analysis population consists of the post-market safety population who are injected with LUMISIGHT. The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 1 trial groupGroup A: Post-market safety population injected with LUMISIGHT
Trial outcomes
Primary outcomes
1
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 injectionSecondary outcomes
1
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 injection2
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 injection3
Distribution of severity of adjudicated hypersensitivity reactions
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
Time frame
75 +/- 15 minutes post LUMISIGHT injection4
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 injectionOther outcomes
1
Change from baseline is tryptase levels for the population that experiences a hypersensitivity event
Characterize the mechanism of action of hypersensitivity reactions occurring after administration of LUMISIGHT by providing a descriptive analysis for tryptase levels in blood and changes from baseline.
Time frame
60 days post hypersensitivity reactionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: