Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Fibroadenoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

ECHOPULSE

Michel NUTA, MD

Jocelyn Acosta

Kathie-Ann Joseph, Prof

Chloe Chhor, Dr

Shubhada Dhage, Dr

Amanda Alonso

Margaret Chen-Seetoo, Dr

Prena Etchen

REIG Beatriu, MD

Katie Rea

David Brenin, Prof

Carrie Rochmann, Dr

Jonathon Nguyen, Dr

This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)

Physician assessment concerning the need of additional procedures

Self assessment satisfaction questionnaire

Theraclion

Gland and Hormone Related Diseases

Thyroid Diseases

Carcinoma

Carcinoma, Papillary

Thyroid Neoplasms

Endocrine System Diseases

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Apply the machine 'Echopulse' with High Intensity Focused Ultrasound to treat the papillary thyroid microcarcinoma.

The participants will be monitored by the doctors actively, like more frequent in follow-up to observe their current situation.

This is a machine to apply high intensity focused ultrasound to ablation the target zone. In this study, we would apply it to the papillary thyroid microcarcinoma.

Echopulse

Hung Hin, Brian Lang, MBBS (Hons)

Papillary thyroid microcarcinoma (PTMC) is a common tumor in Hong Kong. Early immediate surgery has traditionally been recommended. However, given its excellent prognosis, some have recommended Active Surveillance (AS) as an alternative. AS involves monitoring the patients who have PTMC until the tumor progresses. On the other hand, a new technology of ablation has been developing to be an alternative treatment for thyroid nodules comparing with traditional surgery, named High intensity focused ultrasound (HIFU). In our previous study, HIFU is proved in shrinking the size of target site by 6 months gradually and effectively.

The investigator hypothesize that HIFU is an effective treatment for PTMC. Compared to AS, HIFU may be a better option as it not only halts disease progression but also has a longer progression-free survival, longer time to tumor progression and is less likely to harbor active disease.

Differentiated thyroid cancer has been rising in incidence and is expected to be a leading cancer by the year 2030 . However, the rise has been mostly attributed to an increased detection of incidentally-discovered papillary thyroid microcarcinoma (PTMC). PTMC is a papillary thyroid carcinoma (PTC) measuring ≤ 10mm in its greatest dimension. Previous screening and autopsy studies have confirmed these lesions are common and could be found in up to 15% of normal healthy individuals.

However, since the incidence of clinically-significant PTC has historically been \<0.5% (i.e. 100 times less than the occult rate), most occult PTMCs probably do not cause harm in one's life-time and could be safely observed without immediate surgery.

As a result, several groups of investigators worldwide began evaluating the feasibility and safety of observing PTMC without surgery. Rather than offering immediate surgery, well selected patients with low-risk PTMC (i.e. no extrathyroidal extension, nodal and distant metastases) were followed with regular ultrasound (USG) alone and only proceeded to definitive to surgery when the PTMC showed progression. As expected, \>90% PTMCs did not progress and of those who progressed and had surgery, all were cured. This meant even when the initial surgery was deferred, there was no compromise in the chance of cure.

With a recent shift towards a more conservative approach in the management of PTC, it has become increasingly accepted that perhaps active surveillance (AS) might be a safe alternative in well selected low-risk PTMCs.

However, despite the fact that AS is a viable alternative, there are issues and challenges. First, although the majority of occult tumors do not progress initially, the accumulative risk of tumor progression increases with time. From an analysis of the 1479 PTMCs observed over 5 years, 212 (14.3%) eventually met the progression criteria (such as tumor enlargement, local invasion, new lymph node metastasis or becoming clinical disease) and had surgery. Therefore, with longer observation, a greater proportion of patients would end up having surgery. Second some patients tend to find it difficult to accept AS as a treatment. Even if they do initially, the "wait and see" approach may distress patients leading to non-compliance. To date, little is known how this may affect patients' well-being and health-related quality of life (HRQOL) over time. Third, since there are no clinical or molecular parameters to predict which tumors are more likely to progress, patients often need life-long follow-up. However, this may be challenging because patients may move to different places. Lastly, there are now less invasive, non-surgical options available to potentially eradicate PTMCs. Image-guided thermal ablation (IGTA) using laser ablation or radiofrequency ablation appears promising. With technological advances, they may eventually replace surgery in the future. However, reports have so far been non-randomized, uncontrolled and short follow-up. Furthermore, despite being less-invasive, they still require a small skin incision.

High intensity focused ultrasound (HIFU) is a form of IGTA that needs no skin incision or needle insertion and so, is a truly noninvasive treatment. Under USG guidance, it is able to cause irreversible tissue destruction deep to the skin and subcutaneous layer. Apart from being non-invasive, it is less dependent on the operator's skill as the treatment could be controlled by an automated program. In fact, HIFU is highly successful in a number of solid cancers. In the thyroid, it induces tissue damage via the cavitation and thermal effects. To date, several groups (including us) have confirmed that HIFU ablation is highly effective in inducing shrinkage of benign thyroid nodules.

Participants will be arranged into either HIFU group or AS group randomly

A Trial Comparing USG-HIFU vs AS in Management of Low-risk PTMC

A Prospective Randomized Trial Comparing Ultrasound-guided High Intensity Focused Ultrasound (HIFU) Ablation With Active Surveillance (AS) in the Management of Low-risk Papillary Thyroid Microcarcinoma (PTMC)

To compare the proportion of patients with PTMC exhibiting signs of progression between HIFU and AS group at 24 months

To examine the median duration of progression-free survival within 2 years

Tumor volume change from baseline (%) at 2 years

The proportion of patients with active disease confirmed by re-biopsy and CEUSG (%) at 2 years

To calculate the proportion of patients who undergoing thyroidectomy in planned or unplanned.

To examine participants HRQOL during the study with a questionnaire combined with different measurement tools: SF-12 (12-Item Short Form Health Survey), SF-6D (Short Form 6 Dimensions), EQ-5D-5L (EuroQoL 5 Dimensions 5 Levels) and FACT-G (Functional Assessment of Cancer Therapy - general scale). The total score would be the health score of participants, as high score as high quality of life.

To examine any treatment-related side-effects after the treatment

The University of Hong Kong

Clinical Associate Professor

Thyroid Nodule

Roussanka Kovatcheva, Prof.

This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.

Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.

Treatment of Benign Thyroid Nodules With FastScan HIFU

Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)

Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue

High Intensity Focused Ultrasound (HIFU) is a new approach in treating benign thyroid nodule without surgery. It is proven effective and safe relative to traditional surgery. From previous HIFU studies, it caused shrinkage of thyroid nodule up to 70% from original size. Unfortunately, 5-10% of nodule do not shrink. Those which do not shrink are usually large in size and therefore a second HIFU treatment may help. This study is going to evaluate the efficacy and safety of reapplication HIFU after the first single HIFU session in 6 months.

The study will be carried out in the following steps:

1. Recruit subject from the clinic according to the study criteria.
2. Arrange the reapplication HIFU treatment within 3 months.
3. Arrange 4 visits after the HIFU treatment in Post 7 days, Post 1 month, Post 3 months, and Post 6 months; Data collection will be in these 4 visits through the questionnaire or interview by research assistant
4. The subjects will have further health management with the same team after the study.

Thyroid nodules are common and although most are benign and remain relatively static in size, some can grow and become large and cause local symptoms over time. In such scenario, thyroidectomy is usually indicated. However, surgery is not only associated with complications but also with high cost and general anesthesia. As a result, there has been a growing interest in exploring less invasive, non-surgical technique for benign thyroid nodules. For solid or predominantly-solid (\<30% cystic areas) thyroid nodules, thermal ablation techniques have been shown to be highly effective in causing nodule shrinkage and alleviating symptoms in the long-term. To date, numerous thermal ablation techniques have been described and they include radiofrequency ablation (RFA), percutaneous laser ablation (PLA), microwave ablation and more recently, high intensity focused ultrasound (HIFU). HIFU is now considered the least invasive technique as there is no need for needle insertion into the target lesion during treatment. It works by utilizing focused ultrasound energy to generate heat and induce thermal ablation beneath the skin and other tissue layers. Recent studies (including several from our group) have shown that it is effective in not only inducing significant nodule shrinkage but also in alleviating nodule-related symptoms.

However, despite its overall success, approximately 10 - 15% of solid or predominantly solid nodules do not shrink adequately (i.e. \<50% shrinkage from baseline in the first 6-12 months). Although the exact reason why some nodules do not respond remains unclear, it is noted that the majority of these less responsive nodules are larger in size / volume and so, a second or reapplication of ablation might be required to cause further shrinkage and improvement in symptoms \[11\]. However, the role of HIFU reapplication in nodules with less-than-adequate response (\<50% at 6 months) remains undefined. As a result, the present study is aimed to the feasibility and safety of HIFU reapplication in nodules with shrinkage \<50% of baseline volume 6 months after single-session HIFU treatment.

HIFU Reapplication in Benign Nodules

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Reapplication in Benign Thyroid Nodules That Had Less-than Adequate Shrinkage Following Single-session HIFU Treatment.

To measure the change in volume (mL) of the index (or treated) thyroid nodule 6 months following HIFU reapplication

To compare the change in volume (mL) of the treated thyroid nodule between the first single session and the reapplication.

To assess the safety of reapplication HIFU by recording any complications after the treatment

To examine the rate of vocal cord palsy in reapplication HIFU after the first single session in 6 month

To evaluate the cosmetic score (in 0-10) of reapplication HIFU after the first single session in 6 months

To evaluate the pain score (in 0-10) of reapplication HIFU after the first single session in 6 month

The satisfactory level, from scoring in 0-10, to examine how participants' satisfaction in the reapplication HIFU after the first single session in 6 months

Andrea Frasoldati, Dr

Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.

HIFU in Patients With Non-malignant Thyroid Nodules

Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Infections

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Melanoma

Small Cell Lung Carcinoma

Microsatellite Instability

Carcinoma, Transitional Cell

Carcinoma, Merkel Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Genomic Instability

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Small Cell Lung Cancer

Transitional Cell Carcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Pembrolizumab

Atezolizumab

Poly ICLC

Immunoglobulins

Interferons

Immunologic Factors

FUSA therapy and standard of care PD-1 blockade. FUSA therapy will be administered on day 8.

FUSA therapy, standard of care PD-1 blockade, and intratumoral poly-ICLC will be administered on day 8.

FUSA therapy will be administered on day 1.

FUSA therapy and intratumoral poly-ICLC will be administered on day 1.

The Echopulse device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate tissue.

PD-1 therapy FDA approved for use on a 3-week schedule will be used per standard of care.

Standard of Care PD-1 Therapy

Lynn Dengel, MD, MSc

This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with intratumoral poly-ICLC.

Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Pilot Evaluation of Focused Ultrasound Ablation and Focused Ultrasound Ablation Plus PD-1 Antibody Blockade in Advanced Solid Tumors

De-identified individual participant data that underlie the results of this study may be shared.

Incidence and severity of adverse events and incidence of dose-limiting toxicities (DLTs).

Proportion of participants achieving at least a 2-fold increase in CD8+ T cell infiltration per mm2.

Proportion of participants achieving at least a 2-fold increase in CD8+ T cell infiltration per mm2

Craig L Slingluff, Jr

Professor of Surgery; Director, Human Immune Therapy Center

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Pain free if pain at baseline (pain related to the FA)

Cosmetic result (as judged by investigator)

Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12, year 2, 3, 4 and 5 after the HIFU session

Histological outcome through core needle biopsy after 12 month

Energy setting to obtain reduction in volume or total regression of the FA at 12 months, 2, 3, 4 and 5 years follow-up

Quality and ease of use of breast immobilization

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Breast Fibroadenoma Targeted Tissue With HIFU	NCT03044054	Breast Fibroade...	ECHOPULSE	18 Years -	Theraclion
A Trial Comparing USG-HIFU vs AS in Management of Low-risk PTMC	NCT03327636	Papillary Thyro...	Echopulse	19 Years - 74 Years	The University of Hong Kong
A Trial Comparing USG-HIFU vs AS in Management of Low-risk PTMC	NCT03327636	Papillary Thyro...	Echopulse	19 Years - 74 Years	The University of Hong Kong
Treatment of Benign Thyroid Nodules With FastScan HIFU	NCT02491502	Benign Thyroid ...	Echopulse	18 Years -	Theraclion
HIFU Reapplication in Benign Nodules	NCT03331172	Thyroid Nodule	Echopulse	19 Years -	The University of Hong Kong
HIFU in Patients With Non-malignant Thyroid Nodules	NCT02258347	Non-malignant T...	Echopulse	18 Years -	Theraclion
Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors	NCT04116320	Melanoma Breast Cancer Merkel Cell Car... Squamous Cell C... Non Small Cell ... Cervical Cancer Urothelial Carc... Ovarian Cancer Hepatocellular ... Small-cell Lung... Microsatellite ... Gastric Cancer Esophageal Canc...	Echopulse Poly ICLC Standard of Car...	18 Years -	University of Virginia
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)	NCT02011919	Breast Fibroade...	Echopulse	18 Years -	Theraclion

Spots Global Cancer Trial Database for echopulse

Every month we try and update this database with for echopulse 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 echopulse

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