Pancreatic Neuroendocrine Tumors, WHO Grade I-IIERFA-PNETNCT05243082
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
A study testing Radio frequency ablation in people with Pancreatic Neuroendocrine Tumors, WHO Grade I-II, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neuroendocrine Tumors, WHO Grade I-II
- What is being tested?
- Radio frequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jan 2022to 11 Nov 2029
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18
- EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also
- MEN1 patients are eligible:
- PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 <5%, or:
- PNET < 2cm with Ki-67 <10% that has shown progression during surveillance, or:
- PNET 1.5-2 cm with Ki-67 <10% in patients age < 60 years of age, whether progression is detected or not.
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- Distance from the main pancreatic duct ≥2 mm, or <2mm with a prophylactic stent in the main pancreatic duct.
- Patient in good general condition, ECOG performance status 0-2 (see Appendix)
- Signed written informed consent
Who cannot join
- Pregnancy.
- Life expectancy < 1 year
- Severe hemostasis disorders
- Pancreatic and/or biliary ductal dilation
- Evidence of active pancreatitis
- Metastatic disease, including local lymph node metastases
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- Use of anticoagulants that cannot be discontinued
- INR >1.5 or platelet count <50.00
- Distance from the main pancreatic duct <1 mm, and placement of a pancreatic stent is not possible
- Patient being managed for another malignant lesion which is progressive or under treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Espen Thiis-Evensen, MD, PhD, 45039399 ext. 0047, ethiisev@ous-hf.no
Jon Sponheium, MD,PhD, jsponh@ous-hf.no
About this study
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.
- Being tested
- Radio frequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio frequency ablationDevice
Radio frequency ablation of pancreatic neuroendocrine tumors
| Study group | Role | What they receive |
|---|---|---|
| Historical controls | Other | Historical controls Receives: Device: Radio frequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Measured: Up to 12 months
Residual disease
To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Measured: Up to 5 years
Metastatic disease
To register number of patient who develop of local or distant metastases
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start14 Jan 2022
- Primary completion14 Jan 2025 (estimated)
- Study completion11 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine Tumors, WHO Grade I-IIStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Principal investigator, Espen Thiis-Evensen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243082
- Sponsor's protocol ID
- 280305
- Acronym
- ERFA-PNET
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested by other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT05243082
- Acronym / sponsor ID
- ERFA-PNET / 280305
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Jan 2025 (estimated)
- Study completion
- 11 Nov 2029 (estimated)
- First posted
- 16 Feb 2022 (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.
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Historical controls | Other | Device: Radio frequency ablationHistorical controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age above 18
- EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also
- PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 <5%, or:
- Distance from the main pancreatic duct ≥2 mm, or <2mm with a prophylactic stent in the main pancreatic duct.
- Patient in good general condition, ECOG performance status 0-2 (see Appendix)
Key exclusion criteria (10 listed)
- Pregnancy.
- Life expectancy < 1 year
- Severe hemostasis disorders
- Pancreatic and/or biliary ductal dilation
- Evidence of active pancreatitis
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 |
|---|---|---|
| Radio frequency ablationRadio frequency ablation of pancreatic neuroendocrine tumors | Device | Historical controls |
Primary outcome
Adverse events
Time frame: Up to 12 months
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Residual disease
Time frame: Up to 5 years
To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Metastatic disease
Time frame: Up to 10 years
To register number of patient who develop of local or distant metastases
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 30 Mar 2023.
- Individual participant dataSharing planned: Yes. If requested by other investigators.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio frequency ablation in people with Pancreatic Neuroendocrine Tumors, WHO Grade I-II, run by Oslo University Hospital at 1 site in Norway.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Mar 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 Norway. 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?
Contact Espen Thiis-Evensen, MD, PhD (45039399 ext. 0047, ethiisev@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 12 months). The study lists 3 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 30 Mar 2023.