Post-market Safety Study of LUMISIGHT
30 april 2026 uppdaterad av: Lumicell, Inc.
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
1500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: VP, Clinical Affairs and Pharmacovigilance
- Telefonnummer: 6174041033
- E-post: kate@lumicell.com
Studera Kontakt Backup
- Namn: Senior Clinical Trial Manager
- E-post: ppalacios@lumicell.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of adjudicated anaphylaxis
Tidsram: 75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
|
75 +/- 15 minutes post LUMISIGHT injection
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of adjudicated serious hypersensitivity reactions
Tidsram: 75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Incidence of hypersensitivity reactions
Tidsram: 75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Distribution of severity of adjudicated hypersensitivity reactions
Tidsram: 75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Descriptive statistics of population with occurrence of adjudicated anaphylaxis.
Tidsram: 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.
|
75 +/- 15 minutes of LUMISIGHT injection
|
|
Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.
Tidsram: 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.
|
75 +/- 15 minutes post LUMISIGHT injection
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline is tryptase levels for the population that experiences a hypersensitivity event
Tidsram: 60 days post hypersensitivity reaction
|
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.
|
60 days post hypersensitivity reaction
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jorge Ferrer, PhD, Lumicell, Inc.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 december 2030
Avslutad studie (Beräknad)
1 december 2030
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CLP00203
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .