50 Clinical Trials for Various Conditions
To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.
The purpose of this study is to demonstrate the feasibility of an aggressive multimodal approach among patients with stage IV pancreatic cancer (PAC) with isolated, low-volume hepatic metastasis (LVHM). We will evaluate and describe the surgical and overall outcomes of an initial cohort of subjects who undergo pancreatectomy and hepatic resection/ablation for PAC with LVHM. The end of study results will be reviewed by the Hepatiobiliary Multidisciplinary Conference (HDMC) and Surgery Audit Committee (SAC) to determine the appropriateness of adding this treatment arm for patients with oligometastatic metastatic pancreatic cancer.
FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services). A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted against the epidermal growth factor receptor. A second primary aim is to evaluate the safety and tolerability of a chemotherapy/targeted therapy regimen in this patient population. Secondary aims include determination of clinical response rate, recurrence-free survival for patients undergoing complete resection and/or ablation of liver metastases, and overall survival.
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events. Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Medical images used to guide treatment of tumor(s) are presently displayed on flat-panel monitors (like screens used with computers). This protocol will evaluate, using a new headset to view the images in true 3D ("360 degrees"), while using standard flat panel monitors as usual (in accordance with standard of care). The headset is combined with a mini-global positioning system (GPS)-like system to help navigate to treat tumor(s). This evaluation is to show that the headset has potential to provide guidance and navigation information that can improve the treatment of tumor(s) with heat.
In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans. The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan.
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.
This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure reliable tumor treatment. The purpose of this study is to determine the ability of ultrasound echo decorrelation to successfully predict complete ablation of human hepatocellular carcinoma, concomitant diseased liver, and metastatic liver cancer and to determine the potential of echo decorrelation imaging to provide effective real-time control of radiofrequency ablation (RFA) in liver tumors.
This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.
Background: - Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The drug will be given with one of two types of treatment for liver cancer. The first type, transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor through the main blood vessel that is feeding it. That blood vessel is then closed off to help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA), uses a heated probe to destroy the tumor tissue. Researchers want to study how safe and effective these treatments are with the study drug. Objectives: - To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver cancer. Eligibility: - Individuals at least 18 years of age who have advanced liver cancer that has not responded to other treatments.
Background: - Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited disorder that affects how white blood cells function. Liver abscesses in people with CGD often require surgery to remove them and treat the infection. However, some people with CGD cannot have full surgery because it would be too risky. Researchers want to try a procedure called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done without a major operation. This study will see if RFA is a safe and effective treatment for liver abscesses in patients with CGD. Objectives: - To see if RFA is a safe and effective treatment for CGD-related liver abscesses. Eligibility: - Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be treated with surgery. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be performed on the liver. * Participants will have RFA for the abscesses. RFA is an image-guided technique that heats and destroys specific tissue, such as tumor tissue. It will target any abscesses on the liver. * After the procedure, participants will stay in the hospital for monitoring before being released. * Participants will have regular follow-up visits for up to 1 year after treatment. Blood and urine samples will be collected. Additional imaging studies will be performed.
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET imaging, may be effective in detecting residual disease after radiofrequency ablation of liver metastases in patients with colorectal cancer. PURPOSE: This clinical trial is studying fludeoxyglucose F 18-PET imaging to see how well it works for early detection of residual disease in patients undergoing radiofrequency ablation of liver metastases from colorectal cancer.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer. PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.
This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.
The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas \& metastases) within the liver. Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment for liver cancer and cirrhosis. PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed.
The primary purpose of this study is to determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (ipilimumab and nivolumab) in adults with metastatic melanoma with liver metastases who are at significant risk of not benefiting from systemic therapy alone.
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).
Background: - Ablation is a procedure that heats tumor tissue to a high temperature to destroy it. Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the site. Currently, doctors tell what area is heated by using the probe s manufacturer estimates. These estimates are imprecise. Doctors insert small needles to measure the temperature around the area being heated. Doctors also perform scans of the area, but these cannot show which tissue has been heated and which has not. Right now, only contrast scans can show that. But researchers have developed software that uses images from routine scans to create a temperature map. They want to test the software to see if doctors can monitor the procedure without using more needles and without contrast scans. Objectives: - To test software that might help doctors perform ablations better in the future. Eligibility: - People over 18 years of age already scheduled to have an ablation. Design: * Participants will be screened with a medical history. * Participants will visit the clinic for their already-scheduled ablation. The doctor will use the study software to analyze the temperature in the area being heated. The software will not come into contact with a participant s body. - Participants will undergo scans that are necessary for the procedure, but one or two additional scans may be done as part of this study.
Background: Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation). Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver. High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms. Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation. Primary objective: To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter. Eligibility: Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded) Design: Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC. Patients will be monitored using the standard imaging studies when clinically warranted. Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator. The sample size will be 10 evaluable patients
The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked. The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.