Study on Sonoporation and Chemotherapy for Treating Pancreatic Cancer

Sponsor: Flemming Forsberg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04821284

Provider View

This clinical trial is exploring whether adding a new technique called sonoporation to standard chemotherapy can improve treatment outcomes for patients with pancreatic cancer. Sonoporation uses ultrasound and microbubbles to enhance the effects of chemotherapy.

Patient Parameters

Program Overview

This study is testing a new method called sonoporation, which uses ultrasound and tiny bubbles to help chemotherapy work better in treating pancreatic cancer. The goal is to see if this combination can improve how well the treatment works compared to chemotherapy alone. The study is divided into two phases to assess both safety and effectiveness.

Description

The main goal of this study is to see if sonoporation can safely improve the effectiveness of standard chemotherapy for pancreatic cancer, specifically by increasing the time patients live without the cancer getting worse. Researchers are also looking at other effects of sonoporation, such as how long patients can stay on treatment, changes in tumor size, and overall quality of life.

Participants in the study will be randomly assigned to one of two groups:

  • Group 1: Patients will receive standard chemotherapy drugs (gemcitabine and nab-paclitaxel or FOLFIRINOX) along with sonoporation. They will also undergo various imaging tests like CT or MRI to monitor the cancer.

  • Group 2: Patients will receive the same standard chemotherapy without sonoporation and will also have imaging tests to track the cancer.

After completing the treatment, patients will have follow-up visits every three months to monitor their health and any changes in the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a new diagnosis of pancreatic cancer and be scheduled for standard chemotherapy.
  • The cancer must be visible on an ultrasound before starting the study.
  • Must be able to walk and perform daily activities with minimal assistance (ECOG score 0-2).
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
  • Must provide informed consent and agree to follow study procedures.

Exclusion Criteria

  • Participated in another clinical trial within the last week.
  • Have severe lung or heart conditions.
  • Are medically unstable, such as being in critical care or having uncontrolled heart problems.
  • Have severe kidney or liver problems.
  • Have a history of severe allergies to eggs or any component of the study drug Sonazoid.
  • Are pregnant or breastfeeding.
  • Have certain infections like HIV, hepatitis B, or hepatitis C.
  • Have any other reason, as determined by the study doctor, that would make participation unsafe.

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