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

15 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Impedance measurements in different frequencies
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Joseph Friedberg, MD, FACS, University of Maryland, Baltimore

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 mars 2021

Achèvement primaire (Anticipé)

1 septembre 2021

Achèvement de l'étude (Anticipé)

1 décembre 2021

Dates d'inscription aux études

Première soumission

2 mars 2021

Première soumission répondant aux critères de contrôle qualité

15 mars 2021

Première publication (Réel)

18 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HP-00094059

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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