Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
EXACT Therapeutics AS
Study ID
NCT06850623
Phase
PHASE2
Status
Recruiting

Conditions

  • Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acoustic Cluster Therapy — COMBINATION_PRODUCT
    Drug: PS101; Device: Ultrasound
  • Modified FOLFIRINOX — DRUG
    Chemotherapy

Study Details

The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.

Key Dates

Start date
Jun 19, 2025
Status verified
Mar 2026
Primary completion
Dec 15, 2026
Completion
Jul 15, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acoustic Cluster Therapy (ACT) with mFOLFIRINOX

Primary Outcome Measure

ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1. [ Time Frame: From baseline to end of treatment (up to Week 24) ]

Locations (7)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Lu Study Coordinator
(+1) (480) 323 1364
Erkut Borazanci, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer Center Palo AltoStanfordCalifornia94305
Britney Williams
650-736-3688
Isabel Leonio ( Study Coordinator)
Pejman Ghanouni, MD:PhD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical Center - Division of Hematology/OncologyBostonMassachusetts02215
Selma Sinanovic Study Coordinator
+1 617-975-7411
Andrea Bullock, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford CentreDetroitMichigan48202
Christina Vu, Study Nurse
+1 313-556-8107
Maria Diab, MD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Cancer Center, Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Babar Bashir, MD
(215) 955-4279
Priscilla Machado -Sub Investigator, MD, FAIUM
(215) 955-4279
Babar Bashir, MD (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Paul Renz, DO
+1-412-359-3400
Linda Kernrick (Study Coordinator)
Paul Renz, DO (PRINCIPAL_INVESTIGATOR)
Brown University Cancer InstituteProvidenceRhode Island02906
Alexander Raufi, MD
+1 (844) 222-2881
Lindsey Cavanagh Study Nurse
Alexander Raufi, MD (PRINCIPAL_INVESTIGATOR)

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