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New treatment option for Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Official title Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
ClinicalTrials.gov ID: NCT05243082
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.