Neuroendocrine Tumor of Pancreas (Disorder)RFANETNCT04520932
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
A study testing Radiofrequency ablation in people with Neuroendocrine Tumor of Pancreas (Disorder) and Neuroendocrine Tumor Grade 1, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumor of Pancreas (Disorder), Neuroendocrine Tumor Grade 1
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2021to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
Jihane PAKRADOUNI, + 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
Delphine MARIE, + 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
Official title: Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
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.
Read the 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.
- Being tested
- Radiofrequency ablation
- Keywords
- Radio Frequency treatment, Echoendoscopy, Ablation, Efficacy
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.
| Study group | Role | What they receive |
|---|---|---|
| RFA treatment efficacy | Experimental | PNETs ablation by radiofrequency treatment (1 to 3 sessions) Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start30 Mar 2021
- Primary completionApr 2027 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Tumor of Pancreas (Disorder)Studies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice CAILLOL, MD, Principal investigator, Paoli Calmettes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520932
- Sponsor's protocol ID
- RFANET-IPC 2020-003
- Acronym
- RFANET
- Status last verified
- May 2025
- First submitted
- 17 Aug 2020
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size
- ClinicalTrials.gov ID
- NCT04520932
- Acronym / sponsor ID
- RFANET / RFANET-IPC 2020-003
- Keywords
- Radio Frequency treatment, Echoendoscopy, Ablation, Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA treatment efficacy | Experimental | Procedure: Radiofrequency ablationPNETs ablation by radiofrequency treatment (1 to 3 sessions) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®. | Procedure or surgery | RFA treatment efficacy |
Primary outcome
Treatment response
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice CAILLOL, MD principal investigator
Paoli Calmettes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Neuroendocrine Tumor of Pancreas (Disorder) and Neuroendocrine Tumor Grade 1, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihane PAKRADOUNI (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.