Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04520932
Other study ID # RFANET-IPC 2020-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2021
Est. completion date April 2031

Study information

Verified date April 2024
Source Institut Paoli-Calmettes
Contact Dominique GENRE, MD
Phone +33491223778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The primary objective of the study is to evaluate the efficacy of radiofrequency treatment of grade 1 NF-PNETS with a size less than or equal to 2cm. Patients meeting the selection criteria will be included in the study after signing the consent. They will benefit from a RFA treatment consisting of 1 to 3 sessions depending on their response to the treatment. Patients will then be followed for 5 years in order to evaluate their response to treatment, their clinical evolution, their quality of life and any complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date April 2031
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Radiofrequency ablation
RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.

Locations

Country Name City State
France Institut Paoli Calmettes Marseille

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment response Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04464122 - Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
Active, not recruiting NCT06148636 - A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors Early Phase 1
Not yet recruiting NCT06395402 - 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry Phase 2
Enrolling by invitation NCT05111509 - A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent Early Phase 1