Stage III Pancreatic CancerDIRECTNCT03899649
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer
An observational study of Stage III Pancreatic Cancer, run by Angiodynamics, Inc. at 14 sites in United States.
Trial summary
This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Pancreatic Cancer
- What is being tested?
- SOC and NanoKnife System
- Type of treatment
- Medical device
- How many people
- 532 participants
- Where
- 14 sitesUnited States
- Study dates
- 8 May 2019to Apr 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with cytologically or pathologically confirmed Stage 3 PC who are treated, in real-world treatment settings and as part of routine clinical practice, with the NanoKnife System (at least 266 patients) for the ablation of their tumor in addition to SOC (IRE cohort), or with SOC only (at least 266 patients) (SOC cohort). Patients will be enrolled after completing the initial 3-month treatment per SOC for Stage 3 PC.
Who may be able to join
- Provisions of signed and dated informed consent form
- Patient is 18 years of age and older
- Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
- Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
- Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
- Patient has received 3 months of SOC per each participating institution's guidelines
Show all 10Show fewer
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
- Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
- Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC
Who cannot join
- Participation in an interventional trial for pancreatic cancer during the study data collection period
- Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
- Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
- Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Atrium Health
Charlotte, North Carolina, 28204
University of Texas-Southwestern
Dallas, Texas, 75231
St. Luke's University Health Network
Easton, Pennsylvania, 18045
University of Florida Health
Gainesville, Florida, 32608
University of Iowa Healthcare
Iowa City, Iowa, 52242
Moores Cancer Center, UC San Diego Health
La Jolla, California, 92093
Norton Healthcare
Louisville, Kentucky, 40202
Wellstar Medical Group
Marietta, Georgia, 30060
Miami Cancer Institute
Miami, Florida, 33176
NYU Langone
New York, New York, 10016
Presbyterian Hospital, Columbia
New York, New York, 10032
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].
- Conditions
- Stage III Pancreatic Cancer
- Being tested
- SOC, NanoKnife System
- Keywords
- Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor, Pancreatic Carcinoma, Unresectable Pancreatic Cancer, LAPC
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCDrug
Standard of Care treatment
NanoKnife SystemDevice
Irreversible Electroporation
| Study group | Role | What they receive |
|---|---|---|
| IRE Cohort | Patients who received SOC and received IRE Receives: Drug: SOC; Device: NanoKnife System | |
| SOC Cohort | Patients who received SOC and did not receive IRE Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)
Measured: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start8 May 2019
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage III Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 532 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899649
- Sponsor's protocol ID
- 2019-ONC-02
- Acronym
- DIRECT
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.
PubMed 34233640
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03899649
- Acronym / sponsor ID
- DIRECT / 2019-ONC-02
- Conditions
- Stage III Pancreatic Cancer
- Keywords
- Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 Apr 2019 (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.
This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE Cohort | – | Drug: SOC, Device: NanoKnife SystemPatients who received SOC and received IRE |
| SOC Cohort | – | Drug: SOCPatients who received SOC and did not receive IRE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cytologically or pathologically confirmed Stage 3 PC who are treated, in real-world treatment settings and as part of routine clinical practice, with the NanoKnife System (at least 266 patients) for the ablation of their tumor in addition to SOC (IRE cohort), or with SOC only (at least 266 patients) (SOC cohort). Patients will be enrolled after completing the initial 3-month treatment per SOC for Stage 3 PC.
Key inclusion criteria (10 listed)
- Provisions of signed and dated informed consent form
- Patient is 18 years of age and older
- Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
- Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
- Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
Key exclusion criteria (4 listed)
- Participation in an interventional trial for pancreatic cancer during the study data collection period
- Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
- Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
- Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
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 |
|---|---|---|
| SOCStandard of Care treatment | Drug | IRE Cohort, SOC Cohort |
| NanoKnife SystemIrreversible Electroporation | Device | IRE Cohort |
Primary outcome
Overall Survival
Time frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 34233640Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Pancreatic Cancer, run by Angiodynamics, Inc. at 14 sites 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899649, which also lists 1 linked publication.
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 12 Feb 2025.