Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Lung Diseases

Multiple Pulmonary Nodules

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.

Subjects will under a planned procedure with the Ion Endoluminal System

Ion Endoluminal System

Heather Golden, MSc, CCRP

Lindsay Seibel, BSc

Tina Tham, CCRP

Chinh Phan, DO

Kathleen Sanders, MBA, CCRP

Ali Z. Jiwani, MD

Diana Sullivan, MS, RN

Neeraj Desai, MD

Jamie Quigley, RRT, CCRC

Maykol Postigo, MD

Sherae Hereford, RN

A. Rolando Peralta, MD

Karly Pierson, RN, CCRP

Janani Reisenauer, MD

Iulia Basaraba, MD

Bradley Icard, DO

Julie Williams, PhD, MPH

Michael Prichett, DO, MPH

Amy Miller

Alberto Revelo, MD

Sean O'Malley, RN, BSN

Susan Garwood, MD

Samantha Franklin

Ali Abedi, MD, MSc

Valerie Aston, MBA, CCRP

Timothy LeClair, MD

Dina Yassen, MBBS

Hasnain Bawaadam, MD, MPH

Michael Pritchett, DO, MPH

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.

Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Real World Registry for Use of the Ion Endoluminal System

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.

Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale

Intuitive Surgical

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amino Acids

Gemcitabine

Capecitabine

Cisplatin

Pancrelipase

Erlotinib Hydrochloride

Pancreatin

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons.

Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.

Carbon Ion

Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.

All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.

Gemcitabine + Cisplatin

Gemcitabine + Capecitabine

Gemcitabine + Erlotinib

During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.

Photon

Chandan Guha, M.B.B.S., Ph.D.

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer

Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.

Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0

Radiographic changes following completion of study therapy (RECIST v. 1.1)

The length of time from study inclusion until death from any cause

The length of time from study inclusion until death from any cause or disease progression at any site

Quality of life will be assessed at various time points using the European Organisation for Research and Treatment of Cancer 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many cancer related clinical trials.

Shanghai Proton and Heavy Ion Center

Albert Einstein College of Medicine

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine

Spots Global Cancer Trial Database for ion

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

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