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Hyperthermia Treatment for Pancreatic Cancer
N/A
Recruiting
Led By Jason Molitoris, MD
Research Sponsored by NeoTherma Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2
Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial tests a device that uses heat to treat pancreatic tumors, potentially improving blood flow and chemotherapy delivery. It will study the device's safety and performance.
Who is the study for?
Adults over 18 with confirmed pancreatic adenocarcinoma, including high-risk resectable or borderline cases based on NCCN guidelines. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and have proper organ function. Pregnant women are excluded, as well as those with certain heart conditions, blood pressure issues, metal implants incompatible with the device, recent major surgery or other investigational trials interference.Check my eligibility
What is being tested?
The trial is testing VectRx Thermal Therapy combined with standard chemotherapy for pancreatic tumors. The therapy involves a device that heats the tumor to improve chemotherapy delivery. Participants will undergo this treatment four times before their scheduled chemo sessions in an early-stage study assessing safety and performance.See study design
What are the potential side effects?
Potential side effects may include discomfort from heat application, skin irritation at the treatment site, changes in blood pressure during treatment due to heat exposure, and typical chemotherapy-related side effects such as nausea, fatigue, hair loss and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal based on creatinine levels or clearance.
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I don't have active hepatitis B or C.
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I am fully active or can carry out light work.
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I am older than 18 years.
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My cancer is a type of pancreatic cancer confirmed by lab tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance of the VectRx device in its ability to increase temperature in the pancreas
Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].
Trial Design
1Treatment groups
Experimental Treatment
Group I: VectRx Thermal TherapyExperimental Treatment1 Intervention
Device performance
Find a Location
Who is running the clinical trial?
DatabeanIndustry Sponsor
4 Previous Clinical Trials
327 Total Patients Enrolled
University of Maryland, BaltimoreOTHER
688 Previous Clinical Trials
374,651 Total Patients Enrolled
NeoTherma OncologyLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ functions meet the required health standards.I currently have an active infection.My kidney function is normal based on creatinine levels or clearance.I had a heart attack less than 6 months ago.I have pancreatitis.I need medication for heart failure or irregular heartbeat.You are currently being treated with other radiofrequency medical devices.You are expected to live for at least 9 more months.I have had skin cancer or low-risk prostate cancer treated in the last 3 years, but no other cancers.Your waist and chest measurements are larger than the specified size.You have metal or foreign objects inside or attached to your body.I have severe nerve damage in my hands or feet.My blood pressure is either above 100 or below 50 mmHg despite medication.I don't have active hepatitis B or C.My lung function is severely reduced.My HBV DNA is below 500 IU/mL, and if I had HCV, it's cured.You have a metal implant that cannot be taken out and is not safe for certain MRI scans.I have hepatitis B with a viral load over 500 IU/mL.Your disease can be measured using specific imaging tests.My pancreatic cancer is considered high risk but operable, as per NCCN guidelines.I am fully active or can carry out light work.My blood pressure is either above 180 or below 90, even with medication.I am older than 18 years.My cancer has worsened despite current treatment.I have not had major surgery other than for diagnosis in the last 4 weeks.My pancreatic cancer has come back after treatment.I cannot undergo MRI scans.I have had surgery or radiation for pancreatic cancer.I do not have any severe health issues that would stop me from following the study's requirements.My cancer is a type of pancreatic cancer confirmed by lab tests.My cancer type is usually treated with specific regimens.You have metal biliary stents.Women who could become pregnant and are currently breastfeeding or have a positive pregnancy test.I have had multiple strokes or a stroke less than 6 months ago.If you could become pregnant, you need to have a negative pregnancy test when you are screened for the study.Your absolute neutrophil count is at least 1,500 cells/mm3.My cancer has spread to or is affecting my duodenum.I joined the study before or during my first round of chemotherapy.Your AST and ALT liver enzyme levels are less than 2.5 times the normal limit at the testing facility.I have HIV.Your platelet count is higher than 100,000 cells per cubic millimeter.I have severe chest pain due to heart issues, treated with medication.Your bilirubin levels are within a certain range, or slightly higher if you have had a procedure called stenting.I have open skin wounds on my torso.I have a history of lung conditions like interstitial lung disease or sarcoidosis.
Research Study Groups:
This trial has the following groups:- Group 1: VectRx Thermal Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for those interested in participating in this clinical experiment?
"Per clinicaltrials.gov, enrollment for this medical trial has concluded as of July 24th 2023 despite its original posting date being on July 15th. Despite the conclusion of this study's recruitment period, there are currently 720 other studies that are still looking to enlist participants."
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