ACTIVE_NOT_RECRUITING

Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer

Conditions

Locally Advanced Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Unresectable Pancreatic Ductal Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Sonoporation together with chemotherapy may work better in treating patients with pancreatic cancer compared to chemotherapy alone.

Official Title

Optimizing Ultrasound Enhanced Delivery of Therapeutics

Quick Facts

Study Start:2021-12-06

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04821284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must be \>= 18 years old * Patient has a new diagnosis of PDAC and is scheduled to undergo SoC chemotherapy * (International Classification of Diseases \[ICD\]-10 C25.0 Malignant neoplasm: Head of pancreas, C25.1: Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas, C25.3 Malignant neoplasm: Pancreatic duct and C25.9 Malignant neoplasm: Pancreas, unspecified). Any ICD-10 code in the C25 section (malignant neoplasm of pancreas) will be acceptable * Histologically verified, locally advanced (stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas * The PDAC must be visible on grayscale ultrasound prior to injection of ultrasound contrast * Must be ambulatory with an ECOG performance status between 0 and 2 * Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun \> 15 days prior to the screening visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomized partner (6 months minimum). Male patients must also agree to practice throughout the study an approved method of birth control. * Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), and national/local regulations	* Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug * Patient has severe chronic obstructive pulmonary disease, or pulmonary hypertension or unstable cardiopulmonary conditions * Patients who are medically unstable. For example: * Patients on life support or in a critical care unit * Patients with unstable occlusive disease (e.g., crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV) * Patients with recent cerebral hemorrhage * Patients who have undergone surgery within 24 hours prior to the study sonographic examination * Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study in the opinion of the investigator * Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine \>= 1.5 x ULN or calculated creatinine clearance \< 45 mL/min at the screening visit * Patient has severe impairment of liver function, defined as a serum albumin level =\< 25 g/L and/or a prothrombin time international normalized ratio (INR) \> 2.3 (or activated partial thromboplastin time \[APTT\] \> 6 seconds above the upper limit of normal), or a Child Pugh Score C at the screening visit * Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) * Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with non anaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour following the administration of Sonazoid) * Patients that are allergic to any other component of Sonazoid * Any reason why, in the opinion of the investigator, the patient should not participate * Patient is pregnant or is breast-feeding

Inclusion Criteria

Exclusion Criteria

* Patient must be \>= 18 years old
* Patient has a new diagnosis of PDAC and is scheduled to undergo SoC chemotherapy
* (International Classification of Diseases \[ICD\]-10 C25.0 Malignant neoplasm: Head of pancreas, C25.1: Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas, C25.3 Malignant neoplasm: Pancreatic duct and C25.9 Malignant neoplasm: Pancreas, unspecified). Any ICD-10 code in the C25 section (malignant neoplasm of pancreas) will be acceptable
* Histologically verified, locally advanced (stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas
* The PDAC must be visible on grayscale ultrasound prior to injection of ultrasound contrast
* Must be ambulatory with an ECOG performance status between 0 and 2
* Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun \> 15 days prior to the screening visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomized partner (6 months minimum). Male patients must also agree to practice throughout the study an approved method of birth control.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), and national/local regulations

* Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug
* Patient has severe chronic obstructive pulmonary disease, or pulmonary hypertension or unstable cardiopulmonary conditions
* Patients who are medically unstable. For example:
* Patients on life support or in a critical care unit
* Patients with unstable occlusive disease (e.g., crescendo angina)
* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
* Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV)
* Patients with recent cerebral hemorrhage
* Patients who have undergone surgery within 24 hours prior to the study sonographic examination
* Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study in the opinion of the investigator
* Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine \>= 1.5 x ULN or calculated creatinine clearance \< 45 mL/min at the screening visit
* Patient has severe impairment of liver function, defined as a serum albumin level =\< 25 g/L and/or a prothrombin time international normalized ratio (INR) \> 2.3 (or activated partial thromboplastin time \[APTT\] \> 6 seconds above the upper limit of normal), or a Child Pugh Score C at the screening visit
* Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)
* Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with non anaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour following the administration of Sonazoid)
* Patients that are allergic to any other component of Sonazoid
* Any reason why, in the opinion of the investigator, the patient should not participate
* Patient is pregnant or is breast-feeding

Contacts and Locations

Principal Investigator

Flemming Forsberg, PhD

PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Study Locations (Sites)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Flemming Forsberg

Flemming Forsberg, PhD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-06

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-12-06

Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage IIA Pancreatic Cancer AJCC v8
Stage IIB Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Unresectable Pancreatic Ductal Adenocarcinoma