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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
1,500 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov