Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Fluorophosphate

Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus

The 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.

Synapse 3D Lung Modelling

ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.

IC-Green (ICG)

Peter R. A. Malik, BHSc (Honours)

Yogita S Patel, BSc

Wael C. Hanna, MDCM, MBA, FRCSC

Waël C Hanna, MDCM, MBA, FRCSC

With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.

Lungs are made up of individual lobes. When a lung cancer tumour is found in one of these lobes, the surgeon often performs a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue

For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a Segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. Research shows that a segmentectomy can result in less blood loss, shorter operation time, less days of having a chest tube, and a shorter hospital stay, compared to a lobectomy.

With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed in order to safely complete the segmentectomy. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.

In response to these challenges, our surgical group has developed the technique of using Near-Infrared Fluorescence (NIF) mapping with intravascular indocyanine green (ICG) dye injection. With the aid of an infrared camera the surgeon is able to see the segment within a lobe of lung after injection of the ICG dye, allowing for a more accurate segmentectomy. We recently reported a 60% success rate of segmental resections with the use of ICG and NIF-guided surgical resection. However, a limitation to this technique is that the segmental anatomy can only be seen during the operation and only after cutting the blood vessels.

The introduction of 3D reconstruction and virtual modeling provides a new way to locate lesions accurately within a segment and plan the appropriate operation before the actual surgery occurs. Synapse 3D (Mississauga, Canada) is a 3D modelling technology that is capable of producing a detailed 3D virtual model of a patient's lung based on Computed Tomography (CT) scans. It has been shown to be safe and feasible in performing segmental pulmonary resections on a robotic platform. In this study, we propose a new operation that uses 3D anatomical planning before the surgery (Synapse 3D) and real-time NIF-mapping at the time of surgery using ICG dye, which we believe will greatly increase the likelihood of a successful segmentectomy. If this new operation is successful, it will help patients save more of their healthy lung tissue when they are undergoing surgery for lung cancer.

This study is a single centre, prospective clinical trial evaluating the safety and feasibility of adding 3D anatomical reconstructions and real-time intraoperative planning using Synapse 3D software added to NIF-guided targeted segmental resection. It is anticipated that 32 participants will be enrolled within a 1-year period. Enrollment will take place at St. Joseph's Healthcare Hamilton. All patients enrolled will be evaluated until their first scheduled follow-up appointment (within 30 days post-surgery).

Open Label, single-arm feasibility trial.

Synapse 3D With Intravascular Indocyanine Green

Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial

Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy.

Post operative complications will be reported and measured using the Ottawa Thoracic Morbidity and Mortality Classification of (a) Adverse reactions to ICG dye at the time of surgery and (b) Perioperative complications through study completion.

Anatomical accuracy will be evaluated using the criteria listed in points a-c. A score of 3/3 on these items will indicate success of anatomical accuracy

1. Ex-vivo localization of lesions;
2. Ex-vivo confirmation of tumor-free margins around lesion;
3. Ex-vivo confirmation of adequate anatomical inter-segmental.

A pre-operative CT scan based, a pre-operative 3D reconstruction based and post segmental resection surgeon confidence score will be obtained on a scale of 1-5:

1 - not at all confident, 2 - somewhat confident, 3 - confident, 4 - very confident, 5 - extremely confident.

Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room.

Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy. Descriptive analysis of reasons for conversion will also be collected.

Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed.

Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge.

Estimated blood loss will be measured at the time of operation by OR staff.

St. Joseph's Healthcare Hamilton

Director, Research Program, Boris Family Centre for Robotic Surgery

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Inflammation

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

All Canadian MDS patients on the MDS-database to be included.

DNA sequencing for mutations to be obtained by bloodwork within 6 months of diagnosis, or by accessing diagnostic bone marrow aspirate slides.

Genetic Mutations

Bloodwork to be done for lipid profile, c-reactive protein (CRP), and multiplex chemokine/cytokine analysis.

Inflammatory and lipid markers

Sunnybrook Patients with no history of cardiovascular disease \[ex: past/present coronary artery disease (CAD), peripheral vascular disease (PVD), angina, myocardial infarction (MI), stroke, transient ischemic attack (TIA), or stents\], not pregnant, and able to undergo CT will receive a CT of the heart to look for and quantify any occult coronary artery disease.

Computed Tomography (CT) of the heart

Rena Buckstein, MD

Rashmi S Goswani, MD

This study evaluates the relationship between myelodysplastic syndromes (MDS) and cardiovascular disease. MDS patients will be evaluated for the presence of mutations and whether they are associated with an increased risk of heart disease (CVD) and inflammation compared to healthy adults. Patients without symptoms of CVD will receive CT scans to assess for hidden disease and if that is related to their mutations.

Myelodysplastic syndromes (MDS) are a type of blood cancer that can cause infection or bleeding because they prevent the formation of blood components and may lead to leukemia and death. MDS can arise from changes (or mutations) to a patient's DNA. MDS patients have increased risk of heart disease compared to healthy adults. The investigators will look for links between mutations in MDS patients and increased risk of heart disease. They will also use "CT imaging" to see if MDS patients have asymptomatic artery disease but may lead to heart disease in the future and if that is related to their mutations. The researcher will try to link mutations in MDS patients to markers of inflammation and to the amount of artery disease on CT imaging to look for patterns. The goal is to find certain mutations that are associated with inflammation and heart disease. This may ultimately allow hematologists to test MDS patients with these mutations for heart disease and/or treat them early so they have a better and longer life.

Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia

Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular Disease in Patients With Myelodysplasia

Screen for Presence of myeloid-cancer associated mutations and their variant allele frequencies (VAF) at diagnosis of MDS as measured through next generation sequencing of 40 myeloid genes.

Patients at Sunnybrook hospital with no pre-existing history of CAD who receive CT of the heart and found to harbour occult CAD by means of coronary calcium scoring:

1. zero calcium (No CAD)
2. 1-400: mild-moderate calcification
3. \>400: severe calcification

Comparing the presence of myeloid-cancer associated mutations and their variant allele frequencies (VAF) at diagnosis of MDS as measured through next generation sequencing of 40 myeloid genes between patients with pre-existing/occult CAD and those without.

The investigators will track any interventions in patients without a prior history of CAD who who are discovered to have occult CAD by coronary CT. This includes number of patients who were recommended:

1. medical management of CAD
2. Referral to clinical cardiologist
3. Invasive angiography

Measure TNFa, IL-1beta, IL-6 and an array of other inflammatory cytokines (to be determined) in the peripheral blood upon enrollment

Ontario Molecular Pathology Research Network

Queen's University

Sunnybrook Health Sciences Centre

Behaviors and Mental Disorders

Quality of Life

QOL assessments using the ESAS, CPC, EQ5D every 4-8 weeks +/- 2 weeks

CT radiographic imaging every 12 weeks +/- 2 weeks

CT imaging

Samantha Pollard, PhD

Cheryl Ho, MD

This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with targeted therapy that has preliminary evidence of efficacy in subjects with advanced rare cancers or cancer harbouring rare molecular aberrations. The treatment has been granted conditional or full approved by Health Canada (HC) as effective and safe. Due to the rarity of the cancer or molecular aberration the uncertainty level of the health technology assessment (HTA) by the pan Canadian Oncology Review (pCODR) was too high for consideration of funding or it was not submitted for consideration. Consequently, the goal of this study is to generate real world evidence to support HTA decision making throughout the life cycle of the product.

In Canada, adoption of new systemic therapies for cancer treatment is a multi-step process. After completion of clinical trials, pharmaceutical companies submit a request for a new drug approval to Health Canada. Therapies undergo rigorous review at Health Canada to confirm safety and efficacy before a Notice of Compliance (NOC) or NOC conditional (NOC/c) is issued that allows sale of the new medication in Canada. An additional layer of evaluation, a health technology assessment (HTA), is undertaken through the pan Canadian Oncology Drug Review (pCODR). A positive recommendation from pCODR is required for national price negotiations through the pan Canadian Pharmaceutical Alliance (pCPA). Once this step is completed, provincial pharmacies establish local contracts to permit local implementation of the new therapy.

As our understanding of pathogenesis evolves and next generation sequencing becomes more affordable, rare molecular entities amenable to treatment with targeted or selected therapies, like immunotherapy, are being increasingly identified. These molecular aberrations can occur with frequencies of 1-2% making it unfeasible to conduct large randomized trials to establish benefit. Determination of the added value of these new therapies in terms of outcomes and quality of life is challenging in the absence of comparators in trials resulting in increased uncertainty in terms of outcomes, quality of life (QOL) and cost-effectiveness. To address the uncertainty, pharmaceutical companies and the pCODR economic guidance panel create economic models with sensitivity analyses to try to estimate the cost-effectiveness of therapy. These models however, are dependent on the nature and quality of available data.

This study proposes to use real world data to generate evidence to assist in evaluate new therapies in rare molecular entities. The key components include regular interval radiographic imaging and collection of patient reported outcomes using standardized QOL questionnaires. The aim is to provide high quality real world evidence for assessment and economic modelling to reduce uncertainty and facilitate HTA decision-making.

PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc

British Columbia Cancer Agency

Gland and Hormone Related Diseases

Adrenocortical Adenoma

Adrenal Gland Neoplasms

Adenoma

Adrenal Cortex Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Adenoma of the Adrenal Gland

Vasoconstrictor Agents

Respiratory System Agents

Herbal and Botanical

Epinephrine

Racepinephrine

Epinephryl borate

Mace

Nutmeg

Mojca Jensterle, MD, PhD

The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.

After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI \< 25 kg/m2, 25-30 kg/m2 and \> 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.

Natural History of NFAI: 10 Year Follow-up Results

Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results

To determine if and in how many pateints NFAI progressed to MACE.

NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is \< 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded.

MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is \> 50 nmol/l.

To determine the change in size of NFAI on the CT scan (mm).

To determine the change in BMI and its correlation with outcome 1 and 2.

Weight and height will be combined to report BMI in kg/m\^2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Synapse 3D With Intravascular Indocyanine Green	NCT03953144	Non-small Cell ... Primary Neoplas...	Synapse 3D Lung... IC-Green (ICG)	18 Years -	St. Joseph's Healthcare Hamilton
Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia	NCT04110925	MDS Cardiovascular ... Inflammation	Genetic Mutatio... Inflammatory an... Computed Tomogr...	-	Sunnybrook Health Sciences Centre
PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc	NCT04814095	Cancer	QOL CT imaging	18 Years -	British Columbia Cancer Agency
Natural History of NFAI: 10 Year Follow-up Results	NCT04616703	Adrenal Inciden...	CT imaging	18 Years -	University Medical Centre Ljubljana
Synapse 3D With Intravascular Indocyanine Green	NCT03953144	Non-small Cell ... Primary Neoplas...	Synapse 3D Lung... IC-Green (ICG)	18 Years -	St. Joseph's Healthcare Hamilton
Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia	NCT04110925	MDS Cardiovascular ... Inflammation	Genetic Mutatio... Inflammatory an... Computed Tomogr...	-	Sunnybrook Health Sciences Centre
Natural History of NFAI: 10 Year Follow-up Results	NCT04616703	Adrenal Inciden...	CT imaging	18 Years -	University Medical Centre Ljubljana
PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc	NCT04814095	Cancer	QOL CT imaging	18 Years -	British Columbia Cancer Agency

Spots Global Cancer Trial Database for ct imaging

Every month we try and update this database with for ct imaging 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 ct imaging

Every month we try and update this database with for ct imaging 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 ct imaging 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.