Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.

Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.

In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.

Transarterial embolization

Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

Microwave Ablation

Dionisios Vrochides, MD PhD

This is a single-center, prospective RCT to study the effectiveness of TACE and MWA combination therapy with MWA monotherapy for the treatment of early HCC. Primary outcome is 2-year intrahepatic disease-free survival.

This single-center, prospective randomized controlled trial (RCT) is designed to compare the outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0 and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following hypothesis: 2-year intrahepatic disease-free survival does not differ between patients receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient demographics and disease characteristic data and 2) to determine the effect of TAE on radiographic tumor characteristics in this patient cohort.

The primary outcome is 2-year intrahepatic disease-free survival, which is measured from time of randomization and is defined as the absence of local or regional recurrence of HCC as determined by diagnostic imaging. Local recurrence is defined as an enhancing lesion contiguous with the ablation zone that is present on subsequent imaging but was not present on the initial post-ablation scan. Regional recurrence is defined as hepatic recurrence that is not adjacent to the ablation site.

TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial

Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging

Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) from date of treatment until 2 years after that date as determined by diagnostic imaging

Wake Forest University Health Sciences

In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.

Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.

Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

TAE + MWA Combination Therapy

Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.

Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.

MWA Monotherapy

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

United States

Region of Enrollment

Consented Participants

Cirrhosis Present

Ascites Present

History of Hepatic Encephalopathy

History of Ascites

Please Note if any of the following are present (HCV, HPV, Heavy Alcohol use, drug use, nicotine use

Please Note if any previous treatment occured (colon: ablation, tace, chemo, embolization, resection

Please note any previous antiviral therapy the patient has received (IFN, PEG-IFN, Harvon, Other)

Method of diagnosis for HCC - CT

Method of diagnosis for HCC - MRI

Method of diagnosis for HCC - Biospy

Study closed early due to physician decision.

Blair Stephenson, Research Business Manager

The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.

Intrahepatic Disease-free Survival

Overall Survival

Intrahepatic Disease-free Survival - 1 Year

Postoperative Morbidity

Postoperative Mortality

Overall Survival - 3 Years

Overall Survival - 5 Year

Intrahepatic Disease-free Survival - 2 Year

Intrahepatic Disease-free Survival - 3 Year

Intrahepatic Disease-free Survival - 5 Year

Overall Study

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

PAE is performed 6 weeks before radical prostatectomy

Prostatic Artery Embolization (PAE)

Dominik Abt, MD

Livio Mordasini, MD

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.

The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.

Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study

Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.

- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins.

Dominik Abt

Dr. med.

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Leiomyoma

Myofibroma

Uterine Neoplasms

Menorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Hemorrhage

Uterine Hemorrhage

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

Genital Neoplasms, Female

uterine artery embolization

hysterectomy

J.A. Reekers, MD, PhD

The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.

Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.

Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids

Boston Scientific Corporation

ZonMw: The Netherlands Organisation for Health Research and Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma	NCT02704130	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc...	Transarterial e... Microwave Ablat...	18 Years - 75 Years	Wake Forest University Health Sciences
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study	NCT02917161	Prostate Cancer	Prostatic Arter...	45 Years - 75 Years	Cantonal Hospital of St. Gallen
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids	NCT00100191	Menorrhagia Leiomyoma Uterine Neoplas...	uterine artery ... hysterectomy	18 Years -	ZonMw: The Netherlands Organisation for Health Research and Development
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study	NCT02917161	Prostate Cancer	Prostatic Arter...	45 Years - 75 Years	Cantonal Hospital of St. Gallen

Spots Global Cancer Trial Database for therapeutic embolization