Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All biopsy confirmed breast cancer patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Definity

Sonalleve Focused Ultrasound Device

Dr.Gregory Czarnota, MD, Ph.D.

Dr. Gregory Czarnota, PhD, MD

Dr. Gregory Dr. Czarnota, MD, Ph.D.

The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging (MRI)-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

The approach uses relatively low-power ultrasound, operating with lower power levels than high intensity focused ultrasound and ultrasound-based hyperthermia techniques, delivered on the Sonalleve platform. The tumour will be sonicated before the radiation to enhance the effect of therapy. The technique is spatially targeted and stimulates microbubbles using low-power ultrasonic fields in the tumour location only. The primary aim is to evaluate tumour response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic target regions.The secondary aim of this research is to evaluate early and late effect profiles of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after treatment.

Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II

The primary endpoint is complete response in chest-wall tumours and LABC following MRg-FUS + MB + radiation after a 3 month follow up. Patients will be followed clinically thereafter as part of standard of care.

The secondary endpoint will be late effect-reported outcomes at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after treatment (see 8.9).

Terry Fox Research Institute

Sunnybrook Health Sciences Centre

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.

SonoVue

H. Wijkstra, Prof. Dr. Ir.

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.

The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.

Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Prostate cancer detection rate by quantification.

Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?

Prostate cancer Gleason score compared to quantification results

Answering the question: Is there a relation between Gleason score and quantification results?

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Principal Investigator

The study arm includes three parts A, B and C. In part A, the scan protocol, including the injection of the clinically approved contrast agent SonoVue® and the data acquisition time range, is optimized based on the mULM measurements of participants with primary breast cancer.

The following part B consists of 2D-mULM measurements applied to triple-negative breast cancer patients throughout their neoadjuvant chemotherapy cycles with the aim to evaluate to which degree 2D-mULM allows for an assessment of the tumor response during therapy.

In the last part C, participants with neoplasms of uncertain dignity will be investigated by 2D- and 3D-mULM measurements and the accuracy of differentiation between the lesions assessed.

Part A: performing CEUS with the contrast agent SonoVue® at two different doses and two different injection speeds in participants with primary breast cancer

Part B: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants undergoing neoadjuvant chemotherapy

Part C: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants with lesions of unknown dignity

Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)

Elmar Stickeler, Prof Dr. med

Fabian Kiessling, Prof Dr. med

Elmar Stickeler

The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor response to neoadjuvant chemotherapy in participants with a primary breast cancer diagnosis as well as for the differentiation of benign and malignant breast tumors in participants with lesions of unknown dignity.

This study on the clinical translation of the super-resolution ultrasound imaging technique motion-model ultrasound localization microscopy (mULM) is composed of three parts. First, an ultrasound scan protocol will be developed by providing patients with primary breast carcinoma with an ultrasound scan to assess the size, location, and structure of the tumor. Images in the form of B-mode ultrasound, elastography, and contrast ultrasound will be obtained, and mini-movies of the CEUS examinations will be evaluated in a post-processing step. There, individual microbubbles of the ultrasound contrast agent will be identified and tracked to reconstruct the microvasculature of the tumor lesions. Participants will each receive 2 different doses of the clinically approved ultrasound contrast agent SonoVue®. The morphological and functional parameters obtained through the post-processing with the mULM algorithm are then analyzed and subsequently validated with histological examinations. Finally, the ultrasound examination protocol will be optimized and the corresponding dosage of the ultrasound contrast agent determined.

The examination protocol established in the first section will subsequently be applied to patients with primary breast carcinoma receiving neoadjuvant chemotherapy. Contrast-enhanced ultrasonography will be performed at three time points during the chemotherapy cycles and will be performed to assess tumor perfusion through application of the mULM-algorithm. The dosage of contrast agent is based on the dosage found in the previous part of the study. The CEUS examination is followed by the infusion of the chemotherapeutic agent. After completion of neoadjuvant chemotherapy, surgical resection of the tumor and microscopic examination of the tissue are performed according to guidelines.

In the final part of the study, patients with suspected breast tumor lesions are examined. They will first receive non-contrast-enhanced diagnostic ultrasound (B-mode and elastography). A contrast-enhanced ultrasound examination is performed on the largest lesion. To further develop the mULM methodology, this is performed as both 2D and 3D acquisition. The dosage of the contrast agent examination is again based on the optimal dosage found in the first study part. This ultrasound procedure is followed by guideline-guided biopsy for histologic clarification of the tumors, assessing dignity, hormone receptor as well as and HER2/neu status, proliferation rate, and vessel density.

mULM to Support Breast Cancer Diagnosis and Therapy

Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients

The study results will be published in at least one scientific article.

Relative blood volume in % - describes the degree of vascularization - measured with mULM

Change of tumor size determined based on ultrasound B-mode imaging

RWTH Aachen University

Univ.-Prof. Dr. med. Elmar Stickeler, RWTH Aachen University

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumor

Neuroepithelioma

Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

Dr. Gregory Czarnota, MD, Ph.D.

Gregory J Czarnota, MD, PhD

The objective of this study is to examine the safety profile and therapeutic efficacy of MRI-guided focused ultrasound microbubble therapy and radiotherapy in humans.

The approach uses relatively low-power ultrasound, operating with lower power levels than high intensity focused ultrasound and ultrasound-based hyperthermia techniques, delivered on the Sonalleve platform. The tumour will be sonicated before the radiation to enhance the effect of therapy. The technique is spatially targeted and stimulates microbubbles using low-power ultrasonic fields in the tumour location only. the primary aim of this research is to evaluate the safety profile of MRI-guided ultrasound stimulated microbubble treatment and radiation in patients with malignant melanoma. The secondary aim is to evaluate tumour (primary and/or metastasis) response to MRI-guided ultrasound stimulated microbubble treatment and radiation, as measured radiologically within the treated regions.

MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer

The patient will be assessed by a physician investigator and clinical research assistant (CRA) on the MRI-guided focused ultrasound + microbubble (MRgFUS + MB) treatment date and within follow up period of 90 days after treatment.

The secondary aim is to evaluate tumour (primary and/or metastasis) response to MRgFUS + MB and radiation, which will be evaluated by tumour volume change.

Patients with locally advanced breast cancer (LABC) and chest wall tumours will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.

MRI-guided ultrasound-stimulated microbubble-treatment

Definity Suspension for Injection

Dr. Gregory Czarnota, MD

The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device. The investigators have previously demonstrated that ultrasound and microbubble mediated endothelial cell perturbation can significantly enhance the effectiveness of radiation. It enhances tumour response to radiation significantly by synergistically destroying tumour blood vessels. The technique is targeted spatially and achieves tumour specificity by confining the low-power ultrasonic fields that stimulate microbubbles to the tumour location only. By perturbing the tumour vasculature and activating specific genetic pathways, the technique sensitizes the targeted tissues to the subsequent therapeutic application of radiation, resulting in significantly enhanced cell killing. The primary aim of this research is to evaluate the safety profile of MRI-guided ultrasound stimulated microbubble treatment and radiation in patients with chest wall and breast cancer. The secondary aim is to evaluate tumor (primary and/or nodal) response to MRg-FU + MB and radiation, as measured radiologically within the treated therapeutic regions.

Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest Wall and Breast Cancer

Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer

Novel Magnetic Resonance Imaging -Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer

The secondary endpoint is radiological response in breast cancer following MRg-FU + MB + radiation, after a 3 month follow up.

Senior Scientist, MD

Symptoms and General Pathology

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Hematinics

All Drugs and Chemicals

Liver Extracts

Liver metastases randomized to receive sonoporation (US waves + gaseous microbubbles). The patient continue to receive the usual systemic chemotherapy

Liver metatstases not randomized to receive sonoporation (US waves + gaseous microbubbles). The patient continue to receive the usual systemic chemotherapy like the active comparator arm

Perfusion CT scan

Contrast enhanced ultrasound

Gaseous microbubbles (Sonovue) combinated with Ultrasounds

Sonoporation

The oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer.

In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy.

Despite the increasing number of active molecules and the availability of news targeted therapies for cancer, therapeutic achievements remain modest for a number of tumor types. One of the major obstacles is inherent to the absence of specific delivery in the tumor tissue.

We have demonstrated recently that the oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer.

In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy.

The work aims into evaluating the therapeutic efficacy of the proposed approach on a number of selected patients. We will follow the usual treatment schemes and we will apply imaging protocols to visualize tumor progression.

This technique of optimization of the intratumoral availability of anticancer drugs and based on sonoporation will improve the efficacy and safety of systemic chemotherapy by providing increased tumor uptake relative to normal tissue. This technique provides an ideal and easy strategy to optimize intratumoral drug delivery.

Targeted Delivery of Chemotherapy With Ultrasound and Microbublles

Targeted Delivery of Chemotherapy With Ultrasound and Microbubbles

Objective response for liver metastases with spiral CT scan and defined as decrease of at least 30% in the longer diameter of each selected liver metastases

Safety based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE)

Tolerance based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE)

Maximum percent reduction in tumor density (Hounsfield units) from baseline

Maximum percent reduction in tumor density from baseline

Assessment of tumor vascularity with Perfusion CT scan

Assessment of tumor vascularity with Dynamic Contrast-Enhanced US (DCE-US)

Measures of serum concentration of antibody anti-VEGF or anti-EGFR

Pharmacokinetic of antibody anti-VEGF or anti-EGFR

University Hospital, Tours

Gland and Hormone Related Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Pancreatic Ductal

Neoplasms, Glandular and Epithelial

Carcinoma, Ductal

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Folfirinox

1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only

FOLFIRINOX Regime according to Norwegian national guidelines

Chemotherapy

Eva Hofsli, md phd

Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial

Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.

measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment

Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II	NCT06185972	Breast Cancer	Definity Sonalleve Focus...	18 Years -	Sunnybrook Health Sciences Centre
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer	NCT01481441	Prostate Cancer	SonoVue	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
mULM to Support Breast Cancer Diagnosis and Therapy	NCT05445050	Primary Breast ...	Application and...	18 Years -	RWTH Aachen University
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer	NCT05620290	Melanoma	Definity Sonalleve Focus...	18 Years -	Sunnybrook Health Sciences Centre
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer	NCT04431674	Breast Cancer	Definity Suspen...	18 Years -	Sunnybrook Health Sciences Centre
Targeted Delivery of Chemotherapy With Ultrasound and Microbublles	NCT03458975	Colorectal Canc... Hepatic Metasta...	MRI Perfusion CT sc... Contrast enhanc... Sonoporation	18 Years -	University Hospital, Tours
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer	NCT05620290	Melanoma	Definity Sonalleve Focus...	18 Years -	Sunnybrook Health Sciences Centre
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma	NCT04146441	Carcinoma, Panc...	SonoVue Chemotherapy	19 Years - 89 Years	St. Olavs Hospital
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II	NCT06185972	Breast Cancer	Definity Sonalleve Focus...	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for microbubbles

Every month we try and update this database with for microbubbles 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.