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Artichoke

Artichoke WPC 500 mg capsules. Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner. Duration: daily for a period of 90 days.

Artichoke WPC

Paola Muti

This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

In individuals exposed to asbestos and affected with asbestosis or asbestos-related benign pleural disease, and therefore at increased risk of mesothelioma, the investigators will evaluate whether the treatment with the commercially-available Artichoke Whole Phytocomplex Concentrate (Artichoke WPC) for 90 days will decrease mesothelin serum levels.

Although the investigators have general information on toxicity in humans, the investigators will monitor and assess the potential toxicity of Artichoke WPC in this patient population.

In addition to mesothelin, the investigators plan to evaluate the effects of Artichoke WPC on serum microRNAs (miRNAs). The use of miRNAs as minimally-invasive biomarkers has opened new opportunities for the diagnosis of cancer. A number of studies have addressed the potential association of disregulated miRNA profiling and benign asbestos-related disease and mesothelioma. Thus, the investigators will evaluate serum miRNA profiling before and after treatment with Artichoke WPC.

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)

The primary efficacy outcome is based on the reduction in serum concentration levels of mesothelin, measured at baseline and at the end of the intervention for subjects in the efficacy sub-cohort (i.e. for subjects who had elevated mesothelin levels at baseline). A positive outcome will be declared if the biomarker shows a reduction of 25% or more of its baseline value over the 90-day treatment period. For each study subject, mesothelin serum levels for both the baseline and final blood draws will be determined at the same time and in the same batch. This will assist in minimizing the technical variability of the assessments.

At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03.

Aboca Spa Societa' Agricola

Ontario Clinical Oncology Group (OCOG)

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Central Nervous System Depressants

Xenon

Participants will inhale investigational gases (HP 3He, HP 129Xe, PFP and SF6) according to the procedure for that intervention. All participants can potentially inhale all the gases. Magnetic resonance imaging will be performed during breath-holds or continuous breathing (gas-dependent) with the appropriate investigational human lung coil (3He Human Lung Coil, 129Xe Small and Large Human Lung Coil, or PFP and SF6 Human Lung Coil), using the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre.

3He will be hyperpolarized using a custom-built polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of helium gas.

HP 3He

129Xe will be hyperpolarized using a Xemed polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of xenon gas.

HP 129Xe

Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing.

Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing.

The investigational 129Xe small and large quadrature lung coils are sensitive to 129Xe resonant frequencies and therefore will be paired with the investigational drug 129Xe. The size of the coil used will depend on the participants' body size.

129Xe Small and Large Human Lung Coil

The investigational 3He quadrature lung coil is sensitive to 3He resonant frequencies and therefore will be paired with the investigational drug 3He.

3He Human Lung Coil

The investigational PFP and SF6 quadrature lung coil is sensitive to inert fluorinated gas resonant frequencies and therefore will be paired with both PFP and SF6.

PFP and SF6 Human Lung Coil

Mitchell S Albert, PhD

Yurii Shepelytskyi, MSc

Birubi Biman, MD

Karl Granberg, MD

Yurii Shepelytskyi, PhD

The goal of this research is to optimize the MRI system to obtain ideal lung images using Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned to the frequencies of these gases will be used. This study will take place at TBRHSC in the Cardiorespiratory Department and in the Research MRI facility.

MR images of the lung obtained using HP 3He, HP 129Xe, and inert fluorinated gases essentially show the distribution of the inhaled gas inside the lungs. Measurements can be performed on these images to provide additional information that can be related to pulmonary function.

Participation will involve at least two study visits. During the first visit, participants will provide written, informed consent, and undergo eligibility screening. Study drug administration, use of the investigational devices, and MR imaging for this study will be performed at the 3T Research MRI at the Thunder Bay Regional Health Sciences Centre (TBRHSC). Pulmonary Function Tests (PFTs) will be performed at TBRHSC by a Registered Respiratory Therapist (RRT) and an MR Tech will be present for the duration of participant scans.

Participants will be placed in the MRI with the appropriate chest coil wrapped around them like a vest. Several inhalation procedures will be carried out during scanning. Participants safety will be closely monitored throughout the entire study.

Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders

Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders

The primary objective of this study is to determine an optimized set of scan parameters that will produce clear, anatomically and clinically relevant images of the lungs for healthy participants and various types of lung disorder participants, and using one or more gas type (3He, 129Xe, PFP, SF6).

The secondary objective of this study is to correlate the results with PFTs, including spirometry and plethysmography.

Thunder Bay Regional Health Sciences Centre

St. Joseph's Care Group

Lakehead University

Thunder Bay Regional Health Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population	NCT02076672	Asbestos Exposu...	Artichoke WPC	18 Years - 80 Years	Ontario Clinical Oncology Group (OCOG)
Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders	NCT02748798	Lung Transplant Lung Resection Lung Cancer Asthma Cystic Fibrosis Chronic Obstruc... Emphysema Mesothelioma Asbestosis Pulmonary Embol... Interstitial Lu... Pulmonary Fibro... Bronchiectasis Seasonal Allerg... Cold Virus Lung Infection Pulmonary Hyper... Pulmonary Dyspl... Obstructive Sle...	HP 3He HP 129Xe PFP SF6 129Xe Small and... 3He Human Lung ... PFP and SF6 Hum...	18 Years -	Thunder Bay Regional Health Research Institute
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population	NCT02076672	Asbestos Exposu...	Artichoke WPC	18 Years - 80 Years	Ontario Clinical Oncology Group (OCOG)

Spots Global Cancer Trial Database for asbestosis

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

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