Back to results

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors (RFANET)

Primary Purpose

Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Radiofrequency ablation

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor of Pancreas (Disorder) focused on measuring Radio Frequency treatment, Echoendoscopy, Ablation, Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA treatment efficacy

Arm Description

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04520932

First Posted

August 17, 2020

Last Updated

January 5, 2022

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT04520932

Brief Title

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

Acronym

RFANET

Official Title

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

April 2027 (Anticipated)

Study Completion Date

April 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1

Keywords

Radio Frequency treatment, Echoendoscopy, Ablation, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RFA treatment efficacy

Arm Type

Experimental

Arm Description

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment response

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

+33491223778

drci.up@ipc.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrice CAILLOL, MD

Organizational Affiliation

Paoli Calmettes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

GENRE Dominique, MD

Phone

+ 33 4 91 22 37 78

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

GOUARNE Caroline, PhD

Phone

+ 33 4 91 22 37 78

drci.up@ipc.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

We'll reach out to this number within 24 hrs