Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry (IMPACT)
27. mai 2026 oppdatert av: Lumicell, Inc.
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
Lumicell Inc. has developed LumiSystem, a combination product consisting of LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell Direct Visualization System (DVS), a fluorescence imaging device.
U.S. Food and Drug Administration (FDA) approved this combination product on April 17, 2024, for the following indication for use: LUMISIGHT and Lumicell DVS 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 registry study aims to enroll patients for whom LumiSystem has been clinically indicated and used commercially.
This protocol does not direct patient care.
This protocol directs the documentation of information about the care and procedures being provided to patients when using LumiSystem consistent with its approved labeling.
This registry study will collect data on the use of LumiSystem in a real-world setting.
Studietype
Observasjonsmessig
Registrering (Antatt)
1500
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: VP, Clinical Affairs and Pharmacovigilance
- Telefonnummer: 16174041033
- E-post: kate@lumicell.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use
Beskrivelse
Inclusion Criteria:
- Participant must be consistent with FDA approved indication
Exclusion Criteria:
- Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Post market LumiSystem population consistent with FDA approved labeling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients.
Tidsramme: Approximately 7 days
|
Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients.
|
Approximately 7 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine change in margin status after using LumiSystem
Tidsramme: Up to approximately 6 weeks
|
Proportion of patients with at least one positive margin on the index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among all patients and Proportion of patients with at least one positive margin on index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among patients with at least one positive margin on standard lumpectomy.
|
Up to approximately 6 weeks
|
|
Determine impact to adjuvant radiotherapy treatment after using LumiSystem.
Tidsramme: Up to approximately 9 months
|
Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem.
|
Up to approximately 9 months
|
|
Determine impact to surgical intervention after using LumiSystem
Tidsramme: Up to approximately 6 weeks
|
Assess clinical utility of LumiSystem use.
|
Up to approximately 6 weeks
|
|
Compare LumiSystem performance against standard of care (SoC)
Tidsramme: Up to approximately 6 weeks
|
Proportion of LumiSystem-guided shaves that did not contain residual cancer taken after negative margins vs. proportion of standard of care (SoC) shaves that did not contain residual cancer taken after negative margins and proportion of LumiSystem-guided shaves taken after positive margins among positive margins vs. proportion of SoC shaves after positive margins among positive margins.
|
Up to approximately 6 weeks
|
|
Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem.
Tidsramme: Up to approximately 8 weeks
|
Change in healthcare utilization associated with use of LumiSystem
|
Up to approximately 8 weeks
|
|
Identification of safety signals.
Tidsramme: 7 days
|
Rate of adverse events and adverse device effects.
|
7 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. desember 2030
Studiet fullført (Antatt)
1. desember 2030
Datoer for studieregistrering
Først innsendt
21. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLP00205
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Two types of summary reports will be generated annually and shared with the site Investigators: i) one report will summarize the overall dataset ii) the second report will include the site's summary data from their own institute including benchmarks relative to the average without disclosure of the results of other institutions.
IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
Tilgangskriterier for IPD-deling
IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .