The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy (GANNON)

The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Pancreas Cancer; Adenocarcinoma of the Pancreas; Tumor of Pancreas
• Intervention / Treatment: Device: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy

Detailed Description

This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinoma tumors in patients who are diagnosed with unresectable locally advanced (Stage 3) or oligometastatic disease (Stage 4).

The type of design is exploratory and is considered interventional. Following histotripsy, subjects will undergo imaging ≤36-hours post-index procedure. Additionally, subjects will be followed at 7-day, 14-day, 30-day, 60-day, 120-day, and 180-day timepoints.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoe Secord; Phone Number: 612-351-0361; Email: zoe.secord@histosonics.com

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is ≥18 years of age.
2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.

3. Subject is diagnosed with unresectable pancreatic adenocarcinoma, locally advanced (Stage 3) or oligometastatic disease (Stage 4) confirmed via CT or MR imaging ≤30 days prior to the index procedure date.

   NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors and the tumors are located only in the liver and/or lung.

4. Subject is not a surgical candidate and has received chemotherapy ≥16 weeks or subject is intolerant of chemotherapy.

   NOTE: Intolerance is determined after ≥8 weeks of chemotherapy with imaging demonstrating stable or improved disease.

5. Subject can tolerate general anesthesia.
6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.

7. Subject meets the following criteria ≤14 days prior to the planned index procedure date:

   • Hemoglobin ≥ 9 g/dL,
   • Neutrophil count >1.0 x 10^9/L,
   • Platelet >50 x 10^9/L,
   • Total bilirubin ≤2.5x Institutional Upper Limit of Normal (IULN),
   • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5x IULN,
   • International Normalized Ratio (INR) value <1.5,
   • Serum creatinine <2.0mg/dL or an estimated glomerular filtration rate (eGFR) ≥45mL/min.
8. The targeted pancreatic tumor is 2-4 cm in longest diameter.
9. The planned histotripsy treatment volume is ≥1.0 cm from any portion of the duodenum, small intestine, stomach, or colon as visualized on ultrasound, and CT, or MR imaging.
10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.
11. Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors are present in the pancreas.

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
2. Subject has had prior pancreatic, bilioenteric, or gastric surgery.
3. Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
4. Subject has an uncorrectable coagulopathy.
5. Subject has a life expectancy of less than six (6) months.
6. Subject has a biliary or pancreatic stent and/or percutaneous biliary tube.
7. Subject has portal or superior mesenteric vein thrombosis.
8. Subject has ascites.
9. Subject has metastases to organs other than the liver and/or lung (e.g., bone, brain, peritoneum).
10. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
11. Subject has an active duodenal or gastric ulcer requiring medical management.
12. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
13. Subject is undergoing active immunotherapy ≤30 days prior to planned index procedure date.
14. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation).
15. Subject has a planned cancer treatment (e.g., pancreatic surgery, chemotherapy, immunotherapy, etc.) prior to completion of the 30-day follow-up visit.
16. Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency).
17. In the investigator's opinion, histotripsy is not a treatment option for the subject.
18. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
19. Subject's tumor is not treatable by the System's working ranges (refer to User Guide).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HistoSonics System	Device: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy; Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy	Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). [Clinical Events Committee Adjudicated]	30 days post histotripsy procedure

Collaborators and Investigators

• Sponsor: HistoSonics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms
• Other Study ID Numbers: CSP3325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes