- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04804410
Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues
Determination of Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Melissa Culligan, RN, MSc
- Telefonnummer: 4103286366
- E-post: mculligan@som.umaryland.edu
Studer Kontakt Backup
- Navn: Grace Patrice Anyetei-Anum, MS
- Telefonnummer: 8047044661
- E-post: ganyetei-anum@som.umaryland.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joseph Friedberg, MD, FACS, University of Maryland, Baltimore
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HP-00094059
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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