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Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues

15. marts 2021 opdateret af: Joseph S. Friedberg, MD, University of Maryland, Baltimore

Determination of Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues

The purpose of the Dielectrics Properties of Thoracic Malignancies Study (DPTMS) is to provide a wealth of knowledge for investigators involved in establishing a new and effective treatment for a variety of solid tumors using tumor treatment fields. It is intended to provide biospecimen (tumor/healthy) together with demographic data (age, sex, race, occupational history, and other epidemiologic information), and clinical data (stage, treatment, survival information, and annotated CT's). Our specific aims are to test the following hypotheses: 1) Electric properties of thoracic tumors differ from electric properties of surrounding healthy tissue 2) Different tumor types will have different electric properties 3) Electric properties of individual tumors are heterogeneous 4) Electric properties of tumors are related to the structure and composition of the underlying tissue 5) Use of standard medical imaging data (CT) will permit mapping of electric properties.

Studieoversigt

Detaljeret beskrivelse

Thoracic malignancies represent a significant burden of disease in the US population. Lung cancer, for example, is the most common cause of cancer mortality in the US among both men and women and long-term survival remains poor with a 5-year survival rate less than 20%. There is significant need for additional therapeutic options for all stages of patients. Esophageal cancer, although less common in the US with an incidence of 1% among new cancer diagnosis, also has significant mortality with a similar survival rate of about 20% at 5 years. There are a variety of additional thoracic malignancies that contribute to morbidity and mortality of the US population including mesothelioma and other pleural based cancers and thymoma. All of these thoracic malignancies pose unique challenges that have limited the effectiveness of current therapies, necessitating the development of new and innovative approaches.

Tumor treatment fields (TTF) have recently been established as a new and effective treatment for a variety of solid tumor malignancies. TTF provides a unique ability to deliver targeted and sustained therapy via an LCR meter. TTF has shown promise for some of the most aggressive malignancies such as glioblastoma and therefore should be considered for aggressive thoracic malignancies as well. In order to develop a TTF protocol that is both efficient and efficacious, the electric field properties of target tumors must be understood. Although well established for some tumors, the complete electric properties of thoracic malignancies as they apply to TTF is still not fully understood. The proposed project is to address this gap of knowledge.

Our plan is to analyze 3-5 tissue probes acquired from 30 patients with a variety of thoracic malignancies. Tissue will be acquired in the operating room and will be analyzed immediately. The investigators will plan to acquire tissue from each type of malignancy including: lung cancer, esophageal cancer and pleural based tumors. After acquisition of data, the investigators will assess the data and continue to acquire patients to obtain significant estimates of overall tissue properties in each type of tumor. The investigators will offer all patients at our center undergoing resection of thoracic malignancies the opportunity to participate in the study. After undergoing an informed consent process in accordance with IRB approval, patients with be formally enrolled. The LCR meter used for electric property analysis of the tissue will be positioned on and secured to a movable cart so that it can be brought to the operating room for rapid tissue analysis following surgical excision of the tumor. Impedance measurements will be collected on multiple sections of excised tissue and will be translated into dielectric properties. All tumor electric property data will be stored securely and remain anonymous of patient identifying data.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of thoracic malignancies
  • Able to provide informed consent
  • Scheduled for diagnostic or treatment related surgical procedure

Exclusion Criteria:

  • Inability to undergo surgery
  • Unable to provide informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dielectric Properties of Tissue Samples from Thoracic Malignancies and Corresponding Normal Tissues
Our plan is to analyze 3-5 tissue probes acquired from 30 patients with a variety of thoracic malignancies. The investigators will plan to acquire tissue from each type of malignancy including: lung cancer, esophageal cancer and pleural based tumors. Tissue will be acquired in the operating room. Impedance measurements will be collected on multiple sections of excised tissue and will be translated into dielectric properties. After acquisition of data, the investigators will assess the data and continue to acquire patients to obtain significant estimates of overall tissue properties in each type of tumor. After undergoing an informed consent process in accordance with IRB approval, patients with be formally enrolled. All tumor electric property data will be stored securely and remain anonymous of patient identifying data.
The LCR meter is used for electric property analysis of tissues. It works by measuring impedance on multiple sections of excised tissue and translating those measurement into dielectric properties.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impedance measurements in different frequencies
Tidsramme: During Surgery
The impedance measurements in different frequencies will be collected on multiple sections of excised tissue and will be translated into dielectric properties. The conductivity and relative permittivity measurements in frequencies range (20Hz-1MHz) of tissues will be collected and analyzed.
During Surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Joseph Friedberg, MD, FACS, University of Maryland, Baltimore

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2021

Primær færdiggørelse (Forventet)

1. september 2021

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

2. marts 2021

Først indsendt, der opfyldte QC-kriterier

15. marts 2021

Først opslået (Faktiske)

18. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The following information will be recorded from all samples and provided to Novocure Ltd; 1) Type of tumor tissue 2) Measured electric properties 3) ID/ serial number connecting sample to annotated CT image

IPD-delingstidsramme

Individual participant data (de-identified data) would be shared with Novocure Ltd indefinitely.

IPD-delingsadgangskriterier

All individual participant data (de-identified) would be stored on a secure database and shared with Novocure Ltd.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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