Pancreatic CancerNCT05959395
Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors
A study testing VectRx Thermal Therapy in people with Pancreatic Cancer, run by NeoTherma Oncology at 1 site in United States.
Trial summary
In this study, tumors of the pancreas are treated with a device placed around the abdomen that creates an electromagnetic field that generates heat in the tumor. Heating the tumor improves blood flow and the delivery of chemotherapy to the tumor as has been shown in numerous studies for various cancers with potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- VectRx Thermal Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Subjects who are > 18 years old
- Histologically or cytologically proven adenocarcinoma of the pancreas
- Subjects who enrolled prior to- or during initial course of planned chemotherapy.
- Subjects with other histology that would typically receive these regimens are included (i.e. adenosquamous)
- BR and UR Pancreatic Cancer based on modified NCCN guideline will be used as a guide for radiographic findings (94), or high risk resectable pancreatic cancer recommended by a multi-disciplinary team for chemotherapy based on NCCN recommendations (NCCN version 2.2021).
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- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
- Eastern Cooperative Oncology Group (ECOG) performance of 0-1 (Appendix D)
- Estimated life expectancy > 9 months
- If female patient is of child-bearing potential, she must have a negative serum pregnancy test (βhCG) documented at screening
- Subjects who meet the following baseline organ function parameters:
- Absolute neutrophil count >/= 1,500cells/mm3
- Platelets >100,000cells/mm3
- Total Bilirubin ≤1.5X normal institutional limits OR < 2.0 ULN if stenting occurred
- AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal
- Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2
- Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection must meet the following criteria: HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at screening. Subjects with cured hepatitis C virus (HCV) infection at screening can be enrolled but should have HBV DNA levels checked periodically while on study to monitor for reactivation.
- Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-)
Who cannot join
- Subjects with any part of the body between the hips and shoulders >46 inch circumference, with an anterior posterior depth of ~10.5" in a supine position (fit may vary with body shape)
- Subjects unable to tolerate magnetic resonance imaging
- Subjects receiving treatment with other radiofrequency medical devices
- Subject has pacemaker, electrocardiograph, implanted defibrillator, infusion pumps, insulin pumps, cardiac monitoring electrodes and devices, deep brain stimulators, cochlear implants, radiofrequency identification devices attached to devices, or any implanted active electronic device or monitoring system, adhesive skin patches including conductive metal
- Metal biliary stents (plastic stents are allowed)
- Non-removable implanted designated MR unsafe and/or RF incompatible ferromagnetic metallic devices such as metal joint replacements
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- Subjects who have ferromagnetic or electrically conductive, metal, or foreign objects in or on or attached to their body
- Severe pulmonary disease with a forced expiratory volume (FEV) <50%
- Unstable angina pectoris (under medication) with imminent threat of an infarction
- Myocardial infarction <6 months ago
- Cardiac decompensation or arrhythmia necessitating medication
- Systolic blood pressure >180 mmHg and/or <90 mmHg, while using medication
- Diastolic blood pressure >100 mmHg and/or <50 mmHg, while using medication
- Open skin wounds on the torso
- Severe cerebrovascular disease: multiple cerebrovascular accidents (CVA) or a CVA <6 months before treatment
- Subjects having received prior pancreatic surgery, radiation therapy, for pancreatic cancer of any histology
- Subjects with tumors extending to or invading the duodenum
- Subjects with recurrent/relapsed pancreatic cancer
- Progressive disease on pre-protocol enrollment studies for patients already on systemic therapy
- Subjects with pancreatitis
- Subjects in their reproductive age who are breast feeding or have a positive pregnancy test
- Any co-morbid condition such as but not limited to congestive heart failure, cardiac arrhythmia, or psychiatric illness of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
- Concurrent active infection
- Prior malignancies other than cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer within the past 3 years
- Patient with known historical or active infection with HIV
- Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection with HBV deoxyribonucleic acid (DNA) > 500 IU/mL (or 2500 copies/mL) at screening
- Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to screening
- Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- Subjects with greater than grade 2 peripheral neuropathy
- History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirement of the study or to provide consent
- Inability or unwillingness to provide informed consent
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Kelly Kitzmiller, MPH, 410-369-5264, kelly.kitzmiller@umm.edu
Jason Molitoris, MD
About this study
Official title: Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors
In this study, tumors of the pancreas are treated with a device placed around the abdomen that creates an electromagnetic field that generates heat in the tumor. Heating the tumor improves blood flow and the delivery of chemotherapy to the tumor as has been shown in numerous studies for various cancers with potential clinical benefits. Subjects will receive the thermal treatment on the same day and prior to receiving standard of care chemotherapy for a total of 4 treatments. This study is an early feasibility study that aims to demonstrate the safety and the performance of the device.
Read the detailed description
NeoTherma Oncology (NTO) is evaluating the initial safety and device functionality of VectRx, a medical device that produces a locoregional thermal effect through a Radiofrequency (RF)- generated Electromagnetic Field (EMF). VectRx therapy is intended for use as added to standard of care chemotherapy treatment of pancreatic ductal adenocarcinoma (PDAC). This treatment is intended to improve perfusion and re-oxygenate in the tumor microenvironment (TME) of deep solid tumors. This study will enroll up to 5 subjects who will receive treatment with the VectRx device in conjunction with standard of care Chemotherapy. Safety will be evaluated by the type and severity of AEs while functionality (ability to heat) will be assessed using precisely placed temperature probes. Together these results will provide an initial assessment of safety and functionality.
Up to 5 adult subjects with pancreatic adenocarcinoma (primary and metastatic) recommended for chemotherapy based on multi-disciplinary tumor board evaluation including borderline resectable (BR) or unresectable (UR) Locally Advanced Pancreatic Cancer (LAPC), high risk resectable patients felt to benefit from chemotherapy.
- Conditions
- Pancreatic Cancer
- Being tested
- VectRx Thermal Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VectRx Thermal TherapyDevice
Subjects will receive VectRx thermal treatment added to 2 cycles of chemotherapy regimen. The VectRx device will be used under continuous investigator monitoring of internal tissue temperatures via real-time temperature probe data, as well as clinical signs and symptoms reflecting the objectives described above. Up to 5 study subjects will be treated. They will complete VectRx treatment during day 1 prior to 5-FU based (e.g., mFOLFIRINOX) or Gemcitabine based (e.g., Gemcitabine/Nab Paclitaxel) chemotherapy infusion. Thermal treatment will be carefully ramped-up to achieve staged goals of average tumor temperatures between 38°C and 43°C for total treatment times up to 30-70 minutes. The target temperature will be 41.5°C.
| Study group | Role | What they receive |
|---|---|---|
| VectRx Thermal Therapy | Experimental | Device performance Receives: Device: VectRx Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the VectRx device in its ability to increase temperature in the pancreas
Temperature change in patient internal and surface temperature probes measured in degree Celsius during each heat therapy (HT)
Measured: 3 months
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].
AEs including serious adverse events (SAEs), including 1st degree and 2nd degree burns, edema, and abdominal pain will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5 November 2017) during each heat therapy (HT) and chemotherapy (CT) treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start15 Aug 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoTherma Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, Databean
- Responsible party
- Sponsor
- Investigators
- Pierre Floriano, PhD, Study director, NeoTherma OncologyJason Molitoris, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959395
- Sponsor's protocol ID
- GCC 20122
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT05959395
- Acronym / sponsor ID
- GCC 20122
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- NeoTherma OncologyIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, Databean
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, tumors of the pancreas are treated with a device placed around the abdomen that creates an electromagnetic field that generates heat in the tumor. Heating the tumor improves blood flow and the delivery of chemotherapy to the tumor as has been shown in numerous studies for various cancers with potential clinical benefits. Subjects will receive the thermal treatment on the same day and prior to receiving standard of care chemotherapy for a total of 4 treatments. This study is an early feasibility study that aims to demonstrate the safety and the performance of the device.
Detailed description
NeoTherma Oncology (NTO) is evaluating the initial safety and device functionality of VectRx, a medical device that produces a locoregional thermal effect through a Radiofrequency (RF)- generated Electromagnetic Field (EMF). VectRx therapy is intended for use as added to standard of care chemotherapy treatment of pancreatic ductal adenocarcinoma (PDAC). This treatment is intended to improve perfusion and re-oxygenate in the tumor microenvironment (TME) of deep solid tumors. This study will enroll up to 5 subjects who will receive treatment with the VectRx device in conjunction with standard of care Chemotherapy. Safety will be evaluated by the type and severity of AEs while functionality (ability to heat) will be assessed using precisely placed temperature probes. Together these results will provide an initial assessment of safety and functionality.
Up to 5 adult subjects with pancreatic adenocarcinoma (primary and metastatic) recommended for chemotherapy based on multi-disciplinary tumor board evaluation including borderline resectable (BR) or unresectable (UR) Locally Advanced Pancreatic Cancer (LAPC), high risk resectable patients felt to benefit from chemotherapy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VectRx Thermal Therapy | Experimental | Device: VectRx Thermal TherapyDevice performance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Provide signed and dated informed consent form
- Subjects who are > 18 years old
- Histologically or cytologically proven adenocarcinoma of the pancreas
- Subjects who enrolled prior to- or during initial course of planned chemotherapy.
- Subjects with other histology that would typically receive these regimens are included (i.e. adenosquamous)
Key exclusion criteria (32 listed)
- Subjects with any part of the body between the hips and shoulders >46 inch circumference, with an anterior posterior depth of ~10.5" in a supine position (fit may vary with body shape)
- Subjects unable to tolerate magnetic resonance imaging
- Subjects receiving treatment with other radiofrequency medical devices
- Subject has pacemaker, electrocardiograph, implanted defibrillator, infusion pumps, insulin pumps, cardiac monitoring electrodes and devices, deep brain stimulators, cochlear implants, radiofrequency identification devices attached to devices, or any implanted active electronic device or monitoring system, adhesive skin patches including conductive metal
- Metal biliary stents (plastic stents are allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VectRx Thermal TherapySubjects will receive VectRx thermal treatment added to 2 cycles of chemotherapy regimen. The VectRx device will be used under continuous investigator monitoring of internal tissue temperatures via real-time temperature probe data, as well as clinical signs and symptoms reflecting the objectives described above. Up to 5 study subjects will be treated. They will complete VectRx treatment during day 1 prior to 5-FU based (e.g., mFOLFIRINOX) or Gemcitabine based (e.g., Gemcitabine/Nab Paclitaxel) chemotherapy infusion. Thermal treatment will be carefully ramped-up to achieve staged goals of average tumor temperatures between 38°C and 43°C for total treatment times up to 30-70 minutes. The target temperature will be 41.5°C. | Device | VectRx Thermal Therapy |
Primary outcome
Performance of the VectRx device in its ability to increase temperature in the pancreas
Time frame: 3 months
Temperature change in patient internal and surface temperature probes measured in degree Celsius during each heat therapy (HT)
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].
Time frame: 3 months
AEs including serious adverse events (SAEs), including 1st degree and 2nd degree burns, edema, and abdominal pain will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5 November 2017) during each heat therapy (HT) and chemotherapy (CT) treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Floriano, PhD study director
NeoTherma Oncology
Jason Molitoris, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VectRx Thermal Therapy in people with Pancreatic Cancer, run by NeoTherma Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Kitzmiller, MPH ((410) 369-5264, kelly.kitzmiller@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the VectRx device in its ability to increase temperature in the pancreas (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.