NCT04520932 Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
| NCT ID | NCT04520932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Paoli-Calmettes |
| Condition | Neuroendocrine Tumor of Pancreas (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2021-03-30 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2021-03-30 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.
Eligibility 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.
Contact & Investigator
Fabrice CAILLOL, MD
PRINCIPAL INVESTIGATOR
Paoli Calmettes Institute
Frequently Asked Questions
Who can join the NCT04520932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neuroendocrine Tumor of Pancreas (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04520932 currently recruiting?
Yes, NCT04520932 is actively recruiting participants. Contact the research team at drci.up@ipc.unicancer.fr for enrollment information.
Where is the NCT04520932 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT04520932 clinical trial?
NCT04520932 is sponsored by Institut Paoli-Calmettes. The principal investigator is Fabrice CAILLOL, MD at Paoli Calmettes Institute. The trial plans to enroll 82 participants.