Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.

Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.

Contrast Enhanced imaging

FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.

Lumason

Katrina N. Glazebrook, M.B., Ch.B.

Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.

1. Positive predictive value of CEDM in detecting lesions seen on MR
2. Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
3. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
4. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Comparison of Three Methods for Early Detection of Breast Cancer

Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer

The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram

The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

Mayo Clinic

Principal Investigator

Triple Negative Breast Neoplasms

Antineoplastic Agents

Immune Checkpoint Inhibitors

Rebecca Jordan, M.A.

Seth Hardy, M.D.

To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.

Evaluate whether CEUS can predict response on gold standard imaging in the same individuals

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

Milton S. Hershey Medical Center

Assistant Professor - Department of Radiology

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Chlorotrianisene

Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS),

Kathryn McGillen

The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment

This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare.

Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE.

Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit.

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)

Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS.

Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI.

Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS.

Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI.

Number of lesions missed or miscategorized on CEUS imaging.

Number of lesions missed or miscategorized on CT/MRI imaging.

Assistant Professor, Department of Radiology

Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS),

Lumason: 2.4 mL per lesion

Group-1

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Kathryn McGillen, M.D.

Diagnosed with HCC with 1 or more lesions.

Residual Disease on CEUS Imaging.

Residual Disease on CT/MRI Imaging

No Viable Disease on CEUS Imaging.

Diagnosed with HCC with 1 or more lesions

No Viable Disease on CT/MRI Imaging.

3 subjects did not return for routine imaging at 4-8 months.

Lesions Missed or Miscategorized on CEUS Imaging.

Lesions Missed or Miscategorized on CT/MRI Imaging.

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Neoplasms, Nerve Tissue

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Bevacizumab

Angiogenesis Inhibitors

Antineoplastic Agents, Immunological

Growth Inhibitors

Open the BBB using focused ultrasound and microbubble

NaviFUS System

An anti-angiogenic agent to block tumor growth

Sheang-Tze Fung, Ph.D.

Arthur Lung, Ph.D.

Jason Sheehan, M.D., Ph.D.

This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

The study aims to demonstrate the high safety profile and effectiveness of BEV+FUS-MB targeted therapy for brain tumors.

Any patient with a histological diagnosis of GBM who meets all of the specific eligibility criteria may participate in this study by signing informed consent in person or through their legal representative. Eligible patients will undergo a 2-week baseline observation screening period.

Up to 10 eligible patients will be enrolled in this study. Eligible patients will follow the standard operating procedures of BEV (10 mg/kg intravenous (IV) infusion over 30-90 minutes). After at least 30 minutes, patients will be administered microbubbles (MB) (Lumason®) at a dose of 0.1 mL/kg, along with optimal ultrasound exposure doses determined by the acoustic emission feedback FUS power control algorithm of the NaviFUS System. The treatment will be administered every 2 weeks up to 34 weeks or until evidence of progression disease (PD), intolerable toxicity precluding further treatment, non-compliance with study follow-up, or withdrawal of consent, whichever occurs first.

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

The incidence and severity of AEs associated with FUS-MB+BEV treatment in patients with rGBM

PFS-6 is the proportion of patients who remain progression-free at the 6-month time point, as determined by Response Assessment in Neuro-Oncology (RANO) Criteria, from the time of their first treatment.

PFS is defined as the time from the date of first treatment to the earliest date of the first objective documentation of radiographic progression disease based on RANO Criteria, death, or last known follow-up due to any cause whichever occurs first. PFS will be followed continuously till the End-of-Study.

One-year survival rate is the proportion of patients who remain alive at the one-year time point from the time of their first treatment.

OS is defined as the time from the date of first treatment to the earliest date of death or last known follow-up due to any cause whichever occurs first. OS will be followed continuously while subjects are on study and via phone interviews every 3 months during the survival follow-up phase of the study.

ORR is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on a combination of imaging and clinical features as assessed by the RANO Criteria.

CBR is defined as the proportion of patients who achieved an overall response of CR, PR, or SD based on a combination of imaging and clinical features as assessed by the RANO Criteria.

Local disease control is defined as the proportion of patients who achieved a CR, PR, or SD within the planning target tumor lesion, as assessed by the RANO Criteria.

Changes in corticosteroid usage will be compared to baseline.

The standardized and validated European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) and brain cancer questionnaire (QLQ-BN20, assessment specific to brain neoplasm) will be assessed at baseline and throughout treatment period. The changes in QoL during treatment will be compared to baseline. QoL is assessed based on the cancer or brain tumor patient's subjective evaluation of their current status, the presence or absence of the specific symptoms, and their overall general health.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Three Methods for Early Detection of Breast Cancer	NCT03954015	Proliferative B...	Contrast Enhanc... Lumason	30 Years -	Mayo Clinic
Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).	NCT05957042	Breast Cancer Contrast Enhanc...	Lumason	18 Years -	Milton S. Hershey Medical Center
Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).	NCT05957042	Breast Cancer Contrast Enhanc...	Lumason	18 Years -	Milton S. Hershey Medical Center
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE	NCT04569799	Hepatocellular ...	Lumason	18 Years -	Milton S. Hershey Medical Center
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)	NCT06329570	Glioblastoma Mu... Glioblastoma Glioma Brain Tumor Neoplasms Neoplasms, Nerv...	NaviFUS System Lumason Bevacizumab	18 Years -	NaviFUS Corporation
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE	NCT04569799	Hepatocellular ...	Lumason	18 Years -	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for lumason

Every month we try and update this database with for lumason cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lumason

Every month we try and update this database with for lumason cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lumason cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.