Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites

Stage IV Breast Cancer Clinical Trial

Official title:

Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04267575
• Other study ID #: G190165
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: April 14, 2023

Study information

• Verified date: July 2021
• Source: Jerome Canady Research Institute for Advanced Biological & Technological Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study designed is to evaluate the safety of Canady Helios™ Cold Plasma Scalpel (CHCPS) in patients with solid tumors with carcinomatosis scheduled to undergo surgical resection for cytoreduction. Patients with stage 4 resectable tumors as decided by a multidisciplinary disease management team may be included if the metastatic disease is non-synchronous (e.g. recurrent colorectal carcinoma with hepatic metastasis amenable for surgical resection).. Plasma is an ionized gas typically generated in high-temperature laboratory conditions. Plasma coagulators are currently used routinely as surgical tools with multiple applications that create temperatures between 37° C to 43°C and cause thermal injury. Earlier studies demonstrated the non-aggressive nature of cold plasma. As evidence accumulates, it is becoming clear that low-temperature cold plasma has an increasing role in biomedical applications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Solid tumors undergoing surgical treatment with carcinomatosis scheduled to undergo surgical resection for cytoreduction. Patients with stage 4 resectable tumors as decided by a multidisciplinary disease management team may be included if the metastatic disease is non-synchronous (e.g. recurrent colorectal carcinoma with hepatic metastasis amenable for surgical resection).

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study and must be willing to return for follow-up

• 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with Good Clinical Practice (GCP) guidelines and institutional policy.

• Biopsy (histopathology or cytology) diagnosis of a solid tumor as defined by the World Health Organization (WHO) or by cross-sectional imaging reviewed by a board-certified radiologist.

• Good performance status (ECOG < 2), Karnofsky >60%,

• Patients with low or acceptable surgical risk (American society of Anesthesiology (ASA) score of 3 or less.

• Patient is a candidate for surgical therapy as discussed and recommended by the institutional disease management team (DMT, Tumor Board).

At the time of enrollment:

• Absolute neutrophil count (ANC) exceeds 1200/mm3, white blood cell count exceeds 4000/mm3 and platelet count is greater than 100,000/mm3

• An international normalized ratio (INR) = 1.5 (patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible).

• Adequate hepatic function must be met as evidenced by total serum bilirubin = 3.0 mg/dl ; alkaline phosphatase < 2.5 times the upper limit of normal; and, aspartate aminotransferase (AST) less than 1.5 times upper limit of normal [alkaline phosphatase and AST cannot both exceed the upper limit of normal]

• Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

• Life expectancy of at least six months

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Patients with unresectable tumors as decided by a multidisciplinary disease management team

• Patients with multiple metastatic sites not amenable for surgical resection

• Pregnancy or lactation

• Patients with low performance status (ECOG > 2 or Karnofsky < 60%)

• Any one or more of the following hematological abnormalities

• Hgb < 8gm/dl unable to be corrected with transfusion

• Absolute Neutrophil Count < 1200/mm3

• White blood cell count < 4000/mm3

• Platelet count < 100,000/mm3

• INR > 1.5 (except in patients who are therapeutically AST anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for operation will be eligible)

• History of hepatic cirrhosis or present hepatic dysfunction

• Alkaline phosphatase = 2.5 times the upper limit of normal

• = 1.5 times upper limit of normal

• Serum bilirubin > 3.0 mg/dl

• Alkaline phosphatase and AST both exceed the upper limit of normal

• Renal insufficiency indicated by a serum creatinine >1.5mg/dL.

• Patients with high surgical risk (ASA 4-5) with significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease.

• Febrile illness within 7 days before scheduled surgery

• Treatment with another investigational drug or other intervention within 60 days before surgery

• Patients that are unable to- or unwilling to provide a written informed consent

• Patients who underwent treatment with cold plasma within a year before study entry.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Fallopian Tube Neoplasms
• Intestinal Neoplasms
• Lung Neoplasms
• Recurrent Malignant Solid Neoplasm
• Stage IV Bladder Cancer
• Stage IV Breast Cancer
• Stage IV Colon Cancer
• Stage IV Colorectal Cancer
• Stage IV Fallopian Tube Cancer
• Stage IV Gastric Cancer
• Stage IV Liver Cancer
• Stage IV Lung Cancer
• Stage IV Non-small Cell Lung Cancer
• Stage IV Ovarian Cancer
• Stage IV Pancreatic Cancer
• Stage IV Prostate Cancer
• Stage IV Rectal Cancer
• Stage IV Renal Cell Cancer
• Stage IV Small Intestinal Cancer

Intervention

Device:
• Canady Helios Cold Plasma Scalpel
Device used to distribute cold plasma energy at the resected tumor margins.

Locations

Country	Name	City	State
United States	Canady Surgical Group PC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Jerome Canady, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complications Due To Cold Plasma Application	Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.	Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.