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

Pancreatic Cancer Clinical Trial

— GANNON  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282809
• Other study ID #: CSP3325
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: HistoSonics, Inc.
• Contact: Zoe Secord
• Phone: 612-351-0361
• Email: zoe.secord[@]histosonics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas
• Pancreas Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
HistoSonics, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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