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

NCT04804410 | Unknown DMC

• 1 other identifier: HP-00094059
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer; Esophageal Cancer; Mesothelioma; Lung

Keywords

Dielectric Properties; Thoracic Malignancies

Outcome Measures

Primary Outcomes (1)

• Impedance measurements in different frequencies

  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

Study Arms (1)

Dielectric Properties of Tissue Samples from Thoracic Malignancies and Corresponding Normal Tissues

EXPERIMENTAL

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.

Device: LCR Meter (Brand: Keysight, Serial Number:E498AL)

Interventions

LCR Meter (Brand: Keysight, Serial Number:E498AL) DEVICE

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.

Dielectric Properties of Tissue Samples from Thoracic Malignancies and Corresponding Normal Tissues

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to undergo surgery
• Unable to provide informed consent

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• NovoCure Ltd.: collaborator

Related Publications (7)

• Wenger C, Salvador R, Basser PJ, Miranda PC. The electric field distribution in the brain during TTFields therapy and its dependence on tissue dielectric properties and anatomy: a computational study. Phys Med Biol. 2015 Sep 21;60(18):7339-57. doi: 10.1088/0031-9155/60/18/7339. Epub 2015 Sep 9.

  PMID: 26350296 BACKGROUND

• Gabriel C, Peyman A, Grant EH. Electrical conductivity of tissue at frequencies below 1 MHz. Phys Med Biol. 2009 Aug 21;54(16):4863-78. doi: 10.1088/0031-9155/54/16/002. Epub 2009 Jul 27.

  PMID: 19636081 BACKGROUND

• Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1.

  PMID: 28765323 BACKGROUND

• Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

  PMID: 23891283 BACKGROUND

• Ceresoli GL, Aerts JG, Dziadziuszko R, Ramlau R, Cedres S, van Meerbeeck JP, Mencoboni M, Planchard D, Chella A, Crino L, Krzakowski M, Russel J, Maconi A, Gianoncelli L, Grosso F. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019 Dec;20(12):1702-1709. doi: 10.1016/S1470-2045(19)30532-7. Epub 2019 Oct 15.

  PMID: 31628016 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms; Mesothelioma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial

Study Officials

• Joseph Friedberg, MD, FACS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Culligan, RN, MSc

CONTACT

4103286366; mculligan@som.umaryland.edu

Grace Patrice Anyetei-Anum, MS

CONTACT

8047044661; ganyetei-anum@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Thoracic Surgery

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 18, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Individual participant data (de-identified data) would be shared with Novocure Ltd indefinitely.
• Access Criteria: All individual participant data (de-identified) would be stored on a secure database and shared with Novocure Ltd.