Ultrasound Imaging for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to refine and test a new ultrasound imaging technique to better identify cancer in the breast, liver, and kidney. The goal is to determine if this method can more accurately distinguish between malignant (cancerous) and benign (non-cancerous) lesions compared to traditional ultrasound. The study will use Perflutren Lipid, a contrast agent for ultrasound imaging. Healthy volunteers will help optimize the imaging system, while patients with known lesions will undergo sensitivity and specificity tests. Ideal candidates have had an ultrasound at the University of North Carolina, are scheduled for a biopsy, and have visible lesions on ultrasound. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to advancements in cancer detection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this ultrasound imaging technique is safe?
Research has shown that Perflutren Lipid, the treatment under study, has a good safety record from previous uses. The FDA has approved it for improving heart ultrasound images, indicating it has already undergone safety testing in people.
Studies indicate that the treatment is generally well tolerated. Severe allergic reactions are rare, occurring in about 1 in 7,000 people. Although some serious heart or lung issues have been reported, these remain uncommon.
For imaging of the breast, kidney, and liver, Perflutren Lipid has been used to enhance image clarity, aiding doctors in better assessing known lesions. While considered safe, pregnant or nursing women should avoid it.
Overall, existing data suggest that Perflutren Lipid is safe when used as intended.12345Why are researchers excited about this trial?
Researchers are excited about using ultrasound imaging with Perflutren Lipid for cancer detection because it offers a non-invasive way to visualize and assess tumors. Unlike traditional imaging techniques that might require radiation or invasive procedures, this method uses microbubbles that enhance ultrasound signals, potentially providing clearer images of tumors in the breast, kidney, and liver. This approach could lead to earlier and more accurate detection of cancers, which is crucial for successful treatment outcomes. Additionally, it avoids the side effects associated with more invasive diagnostic methods, making it a safer option for patients.
What evidence suggests that this trial's imaging techniques could be effective for evaluating breast, liver, and kidney lesions?
Research has shown that Contrast Enhanced Ultrasound (CEUS) effectively examines lumps or growths in the breast, kidney, and liver. In this trial, participants will undergo assessment using CEUS with Perflutren Lipid. For breast lumps, studies indicate that CEUS successfully highlights 71% of these, including cancerous ones. In kidney imaging, CEUS demonstrates a sensitivity of 96%, correctly identifying most cancerous growths. For liver growths, CEUS reliably distinguishes between non-cancerous and cancerous ones. These findings suggest that CEUS, using Perflutren Lipid, is a promising tool for evaluating growths in these organs.678910
Who Is on the Research Team?
Yueh Lee, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with known lesions in the breast, liver, or kidney from previous imaging studies. It also includes healthy volunteers to optimize the ultrasound system. Participants must be suitable for contrast agent use and willing to undergo CESR imaging.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging Optimization
Healthy volunteers are imaged to optimize system parameters such as frame rate, power, depth of imaging, and linear translation rate.
Imaging Assessment
Patients with known lesions in the breast, liver, or kidney are imaged using CESR to assess sensitivity and specificity compared to traditional B-mode ultrasound.
Follow-up
Participants are monitored for safety and effectiveness after imaging assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Perflutren Lipid
Trial Overview
The study tests Contrast Enhanced Super-Resolution (CESR) imaging's ability to detect and specify lesions in the breast, liver, and kidney compared to traditional B-mode ultrasound. The trial involves 40 participants divided into four groups.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants are going to be assessed liver cancer.
Participants are going to be assessed kidney cancer.
Participants are going to be assessed breast cancer.
Participants without any disease diagnosis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Contrast-Enhanced Ultrasound Imaging of Breast Masses
This pilot study evaluated use of contrast-enhanced ultrasound (CEUS) to reduce the number of benign breast masses recommended for biopsy.
Contrast‐Enhanced Ultrasound Imaging of Breast Masses ...
Of 131 masses, 93 (71%) enhanced on CEUS imaging, including 73 of 109 (67%) benign, 6 of 6 (100%) high-risk, and 14 of 16 (87.5%) malignant.
Characterizing breast lesions using quantitative parametric ...
Earlier detection of breast cancer can yield better treatment outcomes. Currently,. 6 mammography is the primary imaging modality for breast cancer screening in ...
Ultrasound imaging of breast tumor perfusion and ...
In this paper, a novel image processing strategy is detailed for simultaneous measurement of tumor perfusion and neovascular morphology parameters from a ...
Enhancing Targeted Therapy in Breast Cancer by ...
In this review, we will discuss the current classification and standard of care for breast cancer, the application of nanomedicine, and ultrasound-responsive ...
SAFETY DATA SHEET
Pregnant or nursing women should avoid exposure. Medical Surveillance. Employees, who are pregnant, are breast-feeding, or who are concerned ...
Definity (perflutren) injection label - accessdata.fda.gov
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ...
Perflutren - Drugs and Lactation Database (LactMed®) - NCBI
No information is available on the clinical use of perflutren during breastfeeding. Because of the extremely short elimination half-life of perflutren (<2 ...
Perflutren Lipid Microspheres Information
Warning. Very bad heart or lung problems have rarely happened during or after infusion of this medicine (perflutren lipid microspheres).
Definity - accessdata.fda.gov
The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1 ...
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