Clinical trial · Observational
Post-market Safety Study of LUMISIGHT
Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypersensitivity Reactions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Post-market safety population injected with LUMISIGHT
- description
- 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.
Primary outcomes (1)
- measure
- Incidence of adjudicated anaphylaxis
- timeFrame
- 75 +/- 15 minutes post LUMISIGHT injection
- description
- Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
Secondary outcomes (5)
- measure
- Incidence of adjudicated serious hypersensitivity reactions
- timeFrame
- 75 +/- 15 minutes post LUMISIGHT injection
- description
- Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSmith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27. PMID 38320161