Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Radiation Therapy Positioning System (RTPS)

Philip MP Poortmans, MD, PhD

Willy JM de Kruijf, PhD

Karin Haustermans, MD

The study aims to evaluate the safety and performance of the RTPS in patients with localized prostate cancer.The RTPS is an investigational device and requires permanent implantation of a small radioactive fiducial, called the Blip, in the prostate.

The high precision of planned radiotherapy treatments requires accurate positioning of the prostate in order to ensure that the tightly conformed dose distribution does not miss the prostate and result in either significant tumor underdosage, an increased dose to the rectum or bladder, or both. Precise delivery has been addressed using a variety of pre-treatment localization systems. The most direct localization of the prostate involves the use of ultrasound, computed tomography (CT), or radiography of permanently implanted fiducial markers.

In this study the safety and performance of a novel investigational tracking system will be evaluated. The Radiation Therapy Positioning System (RTPS) is a radioactive tracking system integrated into the radiotherapy set-up workflow. The System is composed of the Clinical Positioning System (CPS) and a radioactive soft tissue implanted fiducial (Blip), which is permanently implanted in the prostate. By tracking the implanted Blip, the CPS can monitor positional changes prior to and during the treatment.

The accuracy of the RTPS localization will be compared to the CBCT in at least 5 radiation therapy sessions per patient.

Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer

Navotek Medical, Ltd.

Tal Shchory, COO

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

Hematinics

All Drugs and Chemicals

Liver Extracts

Implantation of fiducials Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days

Fiducials

3 fractions over 8 to 10 days, 15 Gy/fraction

CyberKnife

Xavier MIRABEL, MD

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy.

Stereotaxic radiation by CyberKnife : 3 X 15 Gy over 8 to 10 days for a total of 45 Gy

Stereotaxic Irradiation of Hepatocellular Carcinoma

Stereotaxic Irradiation of Hepatocellular Carcinoma : Phase II Study

Percentage of non-progression 18 months after treatment, according to RECIST criteria

Evaluation of acute tolerance during 90 days after treatment and late tolerance after 90 days, according to NCI CTCAE v3.0 and RTOG criteria.

Percentage of hepatic non progression at 3, 6, 9, 12 months of treatment, according to RECIST criteria.

Time between :

* Date of inclusion
* Date of progression

determination of the best response of treatment, according to RECIST

Questionnaire EORTC QLQ-C30 and QLQ-HCC18

National Cancer Institute, France

Centre Oscar Lambret

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.

Intrafraction Kolovoltage X-ray Imaging using Fiducials

Markerless Tumour Tracking

Carol Kwong, RN

Heidi Tsang, RN

Dasantha Jayamanne, MBBS/FRANZCR

Dasantha Jayamanne, MD

In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.

We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients are implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery and used to calculate online Markerless Tumour Tracking. Markerless Tumour Tracking determines the mean tumour position calculated over the most recent 15 seconds and displays shifts exceeding 3 mm.

The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.

As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.

Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy

Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy

to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.

To identify cohort of patients on which markerless Tumour tracking performs well or poorly

To quantify the accuracy of marker-based tracking by comparison with MV-kV triangulation or visual inspection

To investigate the magnitude of surrogacy of lung tumour motion, ie the difference between tumour motion and implanted marker motion

To investigate the correlation between external and internal motion using infrared/optical imaging

To investigate the suitability and frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods

To investigate the frequency of correcting for tumour baseline shifts based on a variety of tolerance criteria and with different methods

To investigate the feasibility of predicting treatment outcomes based on patient and imaging information

Participants will be followed for 2 years to determine patient outcomes, including radiation therapy toxicity, local control (whether the tumour has spread) and survival

2 year outcomes will be compared to historical outcomes reported from our lung Departmental SBRT database

To record the number of patients ineligible after marker insertion due to positioning of markers, or due to complications with the implantation procedure

To investigate the feasibility of extracting radiomic features from CT, CBCT, and kV images to predict tumour volumes, tracking accuracy, treatment response, and patient outcomes.

To report additional x-ray dose caused by imaging during treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer	NCT00921193	Prostate Cancer	Radiation Thera...	45 Years -	Navotek Medical, Ltd.
Stereotaxic Irradiation of Hepatocellular Carcinoma	NCT01165346	Hepatocellular ...	Fiducials CyberKnife	18 Years -	Centre Oscar Lambret
Stereotaxic Irradiation of Hepatocellular Carcinoma	NCT01165346	Hepatocellular ...	Fiducials CyberKnife	18 Years -	Centre Oscar Lambret
Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging for Lung Cancer Radiotherapy	NCT04310891	Lung Cancer Markerless Imag... Intrafraction K...	Markerless Tumo...	18 Years - 80 Years	Royal North Shore Hospital

Spots Global Cancer Trial Database for fiducials

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

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