Using radiofrequency ablation to treat pancreatic neuroendocrine tumors
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
This study is testing if a treatment called radiofrequency ablation can help people with small, nonfunctioning pancreatic tumors feel better and have fewer worries compared to current monitoring methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT04520932 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of radiofrequency ablation (RFA) for treating grade 1 nonfunctioning pancreatic neuroendocrine tumors (NF-PNETs) that are 2 cm or smaller. Patients will undergo 1 to 3 RFA sessions based on their treatment response and will be monitored for 5 years to assess their clinical outcomes, quality of life, and any complications. The aim is to provide a less costly and anxiety-inducing alternative to the current monitoring practices for these tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a biopsy-confirmed diagnosis of grade 1 NF-PNETs measuring 2 cm or less.
Not a fit: Patients with larger tumors, severe health conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a less invasive and more effective management option for patients with small pancreatic neuroendocrine tumors.
How similar studies have performed: While only a few small studies have evaluated this treatment, the results have been encouraging, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI; * Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\<3%, * Non-secretory lesion. * Homogeneous HEE contrast taking; * No positron emission tomography (PET) FDG binding to the pancreatic mass; * Lesion \<20mm on conventional imaging at 6 months monitoring; * Age 18 to 80 years inclusive; * Patient in good general condition, World Health Organization \[0-1\]; * Signed consent to participate; * Affiliation to healthcare insurance system or beneficiary of this regimen. Exclusion Criteria: * Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ; * A person in an emergency situation or deprived of liberty or placed under the authority of a tutor. * Life expectancy \< 1 year; * Severe hemostasis disorders; * Pancreatic and/or biliary ductal dilation; * Lesion considered to be adjacent to the pancreatic duct and/or bile duct; * Node extension and/or metastatic disease; * Patient being managed for another malignant lesion which is progressive or under treatment.
Where this trial is running
Marseille
- Institut Paoli Calmettes — Marseille, France (Recruiting)
Study contacts
- Principal investigator: Fabrice CAILLOL, MD — Paoli Calmettes Institute
- Study coordinator: Jihane PAKRADOUNI
- Email: drci.up@ipc.unicancer.fr
- Phone: +33491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.