NCT06371716

Brief Summary

The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control. The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

March 25, 2024

Last Update Submit

April 15, 2024

Conditions

Pancreatic CancerEndoscopic UltrasoundRadiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation

    assesses by two blinded pathologists

    within 15-20 days

Study Arms (3)

resected PDAC without neoadjuvant chemotherapy treatment

EXPERIMENTAL

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Procedure: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions

resected PDAC with neoadjuvant chemotherapy treatment

EXPERIMENTAL

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Procedure: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions

resected neuroendocrine tumors

EXPERIMENTAL

Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)

Procedure: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesionsProcedure: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions

Interventions

ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesionsPROCEDURE

5 PDAC with neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 PDAC without previous neoadjuvant chemotherapy treated at 10 W with ex-vivo RFA 5 NET treated at 10 W with ex-vivo RFA

resected PDAC with neoadjuvant chemotherapy treatmentresected PDAC without neoadjuvant chemotherapy treatmentresected neuroendocrine tumors
ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesionsPROCEDURE

5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs

resected PDAC with neoadjuvant chemotherapy treatmentresected PDAC without neoadjuvant chemotherapy treatmentresected neuroendocrine tumors
ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesionsPROCEDURE

5 PDAC with neoadjuvant chemotherapy 5 PDAC without previous neoadjuvant chemotherapy 5 NETs

resected PDAC with neoadjuvant chemotherapy treatmentresected PDAC without neoadjuvant chemotherapy treatmentresected neuroendocrine tumors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 17, 2024

Study Start

September 12, 2019

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)