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Chemotherapy
Sonoporation + Chemotherapy for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By Flemming Forsberg, PhD
Research Sponsored by Flemming Forsberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically verified, locally advanced (nonresectable stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas
Patient must be >= 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether a new method called sonoporation, which uses ultrasound and microbubbles, can increase the effectiveness of chemotherapy in treating pancreatic cancer.
Who is the study for?
Adults over 18 with a new diagnosis of inoperable pancreatic cancer, visible on ultrasound, who can undergo standard chemotherapy. They must not be pregnant or breastfeeding and agree to use contraception. Participants should be relatively mobile (ECOG status 0-2) and have adequate blood counts and liver function.Check my eligibility
What is being tested?
The trial is testing sonoporation—a technique using ultrasound and microbubbles—combined with standard chemotherapy drugs for pancreatic cancer treatment. The goal is to see if this combination is more effective than chemotherapy alone.See study design
What are the potential side effects?
Potential side effects include reactions related to the contrast agent used in sonoporation, such as allergy-like symptoms, plus typical chemotherapy side effects like nausea, fatigue, low blood cell counts leading to increased infection risk, nerve damage causing numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is an advanced or spread pancreatic cancer.
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I am 18 years old or older.
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I have been diagnosed with inoperable pancreatic cancer and will start standard chemotherapy.
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I can walk and care for myself with little to no help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Contrast enhanced ultrasound data
Number of chemotherapy cycles a subject can tolerate
Overall survival
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (sonazoid, ultrasound, chemotherapy)Experimental Treatment11 Interventions
Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel IV over 60 minutes on days 1, 8 and 15 OR FOLFIRINOX IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients also receive sonazoid IV over 20 minutes and undergo CEUS. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study.
Group II: Arm II (chemotherapy)Active Control9 Interventions
Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel IV over 60 minutes on days 1, 8 and 15 OR FOLFIRINOX IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Contrast-Enhanced Ultrasound
2018
Completed Early Phase 1
~50
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Oxaliplatin
2011
Completed Phase 4
~2560
Nab-paclitaxel
2014
Completed Phase 3
~2030
Leucovorin Calcium
2011
Completed Phase 3
~12310
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,281 Total Patients Enrolled
Flemming ForsbergLead Sponsor
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,369 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced pancreatic cancer and severe liver issues.Your white blood cell count is not too high.I am currently on life support or in a critical care unit.My cancer is an advanced or spread pancreatic cancer.I have worsening chest pain due to heart artery blockage.I do not have uncontrolled heart rhythm problems.Your AST and ALT levels in your blood should not be more than three times the upper limit of normal.Your platelet count is higher than 100 billion per liter before joining the study.Your neutrophil count is higher than 3.5 x 10^9 per liter before joining the study.Your bilirubin levels are within a certain range before joining the study.I have had pulmonary vasculitis or a history of blood clots in my lungs.I had surgery less than 24 hours before a planned ultrasound exam.I am 18 years old or older.You are allergic to any other ingredient in Sonazoid.The pancreatic ductal adenocarcinoma (PDAC) must be visible on a grayscale ultrasound before the injection of ultrasound contrast.I have been diagnosed with inoperable pancreatic cancer and will start standard chemotherapy.I have severe lung disease or unstable heart/lung conditions.I am using effective birth control and have a negative pregnancy test.I can walk and care for myself with little to no help.I do not have severe, uncontrolled heart failure.I require dialysis or have severe kidney problems.My liver is not working well, shown by specific blood test results.I have had a severe allergic reaction to eggs or egg products.Women who cannot become pregnant naturally due to menopause or surgical sterilization can participate in the study.Your hemoglobin level should be higher than 10 grams per deciliter before joining the study.I have had a recent brain bleed.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (sonazoid, ultrasound, chemotherapy)
- Group 2: Arm II (chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main reason that Contrast-Enhanced Ultrasound is used?
"Contrast-Enhanced Ultrasound is a therapeutic modality with potential to improve patient outcomes for malignant neoplasms such as non-small cell lung carcinoma, rectal carcinoma, and colorectal carcinoma."
Answered by AI
What is the projected total number of participants for this research project?
"That is accurate, the latest information from clinicaltrials.gov says that this study is still looking for enrollees. 120 people are needed for the trial which is being conducted at a single location. The posting went up on December 6th, 2021 and was last updated 12/15/2021."
Answered by AI
Are we still able to sign people up for this research project?
"That is correct. The clinicaltrials.gov website provides updated information on this trial, which was first posted December 6th 2021 and most recently updated December 15th 2021. The study is looking for 120 patients at 1 site."
Answered by AI
Are there any other investigations that have used Contrast-Enhanced Ultrasound?
"Contrast-Enhanced Ultrasound is currently being trialled in 1700 different medical studies, 495 of which have progressed to Phase 3. While Guangzhou, Guangdong has a significant presence in these investigations, Contrast-Enhanced Ultrasound trials are running globally at 83029 locations."
Answered by AI
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