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A Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures

30. oktober 2026 oppdatert av: Teresa Boitano, University of Alabama at Birmingham

Pilot Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures

This is a pilot project to determine the safety and feasibility of using panitumumab-IRDye800 to detect cancerous tissue compared to normal surrounding tissue in participants with ovarian cancer undergoing surgical resection. This study is an extension of the work previously done using this agent in patients with squamous cell carcinoma (SCC) of the head and neck, exploring its utility in a different cancer type.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study is an open label, single site, Phase I study to determine the safety and feasibility of using conjugated panitumumab-IRDye800 in patients with ovarian cancer undergoing surgical resection. Tumor to background ratios (TBRs) will be determined by comparing fluorescence intensity of tumor tissue to grossly normal tissue in the field. The presence of tumor tissue and fluorescence will be confirmed by histopathologic analysis.

Panitumumab-IRDye800CW has a toxicity and pharmacodynamic profile that matches the parent compound. In this study, patients will receive a 50mg flat dose of panitumumab-IRdye800 without a loading dose of panitumumab alone, which was found in the Phase I study of patient with head and neck cancer to be the safest and most cost-effective dose in a dose-range escalation study with high sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for fluorescence detection of tumor compared to normal background tissue. This infusion will occur 24-72 hours prior to planned surgery.

Studietype

Intervensjonell

Registrering (Antatt)

6

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Michelle Osoinak, BSN, RN, CNOR
  • Telefonnummer: 205-539-2903
  • E-post: mosoinak@uabmc.edu

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • University of Alabama at Birmingham
        • Underetterforsker:
          • Jason Warram, PhD
        • Hovedetterforsker:
          • Teresa Boitano, MD
        • Ta kontakt med:

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. Biopsy-confirmed diagnosis of ovarian cancer.

  2. Diagnosis of any stage.

  3. Diagnosis of any histology.

  4. Planning to undergo surgical resection via any modality (i.e., open, laparoscopic, robotic) with primary cytoreduction or interval debulking following neoadjuvant chemotherapy.

  5. Age ≥ 18 years

  6. ECOG 1

  7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:

    1. Hemoglobin ≥ 9 gm/dL
    2. Absolute Neutrophil Count ≥ 1500
    3. White Blood Cell count > 3000/mm3
    4. Platelet count ≥ 100,000/mm3
    5. Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

  1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
  3. History of infusion reactions to any monoclonal antibody therapies
  4. Pregnant or breast-feeding
  5. Evidence of QT prolongation on pretreatment EKG (greater than 440 ms in males or greater than 450 ms in females)
  6. Magnesium or potassium lower than the normal institutional values
  7. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  9. TSH > 13 micro International Units/mL

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Patients requiring surgical resection of ovarian cancer

Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.
Legemiddel: Panitumumab-IRDye800

Single IV systemic infusion of panitumumab-IRDye800 and NIR imaging of cancer during and after surgical resection.

Enrolled patients will receive a one-time IV infusion of 50mg of the investigational agent, panitumumab-IRDye800, 24-72 hours prior to the scheduled surgical resection. All appropriate labs, tests, and safety monitoring will occur as outlined in Section 8.1. Participants will be monitored using standard clinical parameters to evaluate for toxicity. Participants will be observed immediately after infusion of the study drug. The following observations and tests shall be performed after treatment to identify both acute and late treatment specific toxicity: vital signs, physical exam, toxicity grading, assignment of performance status, hematology, and blood chemistries (complete metabolic profile to include magnesium and phosphorus). NCI Common Toxicity Criteria v5.0 will be used for grading of toxicity.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Dose limiting toxicity (DLT)
Tidsramme: up to 15 days after infusion

Dose limiting toxicity (DLT) defined as any grade 2 or greater toxicity that is considered definitely related to the study drug, considered clinically significant by the Principal Investigator, and occurs within 15 days of receiving treatment.
up to 15 days after infusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Etterforskere

  • Hovedetterforsker: Teresa Boitano, MD, University of Alabama at Birmingham

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.

Generelle publikasjoner

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. november 2026

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

30. oktober 2026

Først innsendt som oppfylte QC-kriteriene

30. oktober 2026

Først lagt ut (Faktiske)

5. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00000341
  • UAB (Annen identifikator: UAB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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