Hypersensitivity ReactionsNCT07572162
Post-market Safety Study of LUMISIGHT
An observational study of Hypersensitivity Reactions, run by Lumicell, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Reactions
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2026to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Senior Clinical Trial Manager contact
United States2 sites, 2 recruiting
- Recruiting
University of South Alabama Health
Mobile, Alabama, 36604
Tiffany Hill, 251-445-3276, tnfulford@health.southalabama.edu
Spencer Liles, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Trudy Sea-Eun Kim, (650) 498-1106, trudykim@stanford.edu
Irene Wapnir, MD
About this study
Official title: Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
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.
Read the 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.
- Conditions
- Hypersensitivity Reactions
- Keywords
- Lumicell, LumiSystem, LUMISIGHT, Breast Cancer, Intraoperative margin detection, anaphylaxis, hypersensitivity, drug allergy, post-market safety, fluorescence guided surgery
- Medical subject headings
- Hypersensitivity, Breast Neoplasms, Anaphylaxis, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-market safety population injected with LUMISIGHT | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adjudicated anaphylaxis
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Secondary outcomes (5)
Incidence of adjudicated serious hypersensitivity reactions
Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Incidence of hypersensitivity reactions
Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Distribution of severity of adjudicated hypersensitivity reactions
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
Measured: 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.
Measured: 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.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 Sep 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Ferrer, PhD, Principal investigator, Lumicell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572162
- Sponsor's protocol ID
- CLP00203
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith 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.
PubMed 38320161