Panitumumab-IRDye800 til påvisning af kræft hos deltagere med lungekræft under operation
Et fase I/II-studie, der evaluerer sikkerheden og farmakokinetikken af Panitumumab-IRDye800 som et optisk billeddannende middel til påvisning af lungekræft under kirurgiske procedurer
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.
II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.
OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.
Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
After completion of study treatment, participants are followed up for up to 30 days.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Natalie Lui
- Telefonnummer: 650-721-2086
- E-mail: natalielui@stanford.edu
Studiesteder
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California
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Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- Stanford University, School of Medicine
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Ledende efterforsker:
- Natalie Lui
-
Kontakt:
- Natalie Lui
- Telefonnummer: 650-721-2086
- E-mail: natalielui@stanford.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
- Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
- Hemoglobin ≥ 9 gm/dL
- White blood cell count > 3000/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 1.5 times upper reference range
Exclusion Criteria:
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Prisoners, institutionalized individuals, and patients unable to consent for themselves
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days. |
Undergo surgery Undergo imaging
Andre navne:
Given IV
Andre navne:
Correlative studies
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor to background ratio (TBR), measured in ex vivo tissues
Tidsramme: Up to 1 year
|
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery). |
Up to 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antallet af grad 2 eller højere AE'er bestemt til at være klinisk signifikante og definitivt, sandsynligvis eller muligvis relateret til studielægemidlet
Tidsramme: Op til 30 dage
|
Op til 30 dage
|
|
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Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Tidsramme: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify metastatic lesions. Outcomes will be reported as the number of metastatic lesions detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
Tidsramme: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify tumor-positive lymph nodes. Outcomes will be reported as the number of tumor-positive lymph nodes detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Tidsramme: Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify residual disease at resection margins. Outcomes will be reported as the number of positive-margins detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Natalie Lui, Stanford University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-41302
- NCI-2018-00494 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- LUN0099 (Anden identifikator: OnCore)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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