Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Prostatic Neoplasms

Lung Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.

Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy

Cone Beam Computed Tomography

Corinne Faivre-Finn, MD PhD

Julie Stratford

Corinne Faivre-Finn

Ananya Choudhury

The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered.

Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality.

The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.

Simultaneous CBCT Acquisition During Arc Radiotherapy

Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy

To show equivalence of image quality from simultaneous CBCT acquisition during delivery of arc radiotherapy with that obtained from conventional CBCT acquisition in lung and prostate patients, as assessed by user-questionnaires.

To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.

To quantify inter-observer variation in delineation of specific structures on CBCT scans.

To quantify the impact of simultaneous CBCT scans on treatment times.

Sally Falk

Clinical Trial Project Manager

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

This research study involves a screening period, a procedure and follow up visits

* Procedure Visit Navigation Bronchoscopy Alone
* Follow-Up Visits at Week 1, 4 and 12

This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules

-Follow-Up Visits at Week 1, 4 and 12

Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.

Navigation Bronchoscopy

Cone beam computed tomography (CBCT)

Adnan Majid, MD

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.

The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.

The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.

This research study involves a screening period, a procedure and follow up visits.

The names of the study interventions involved in this study are:

* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone

Participants will receive the study procedure and will be followed for up to 6 months.

It is expected that about 136 people will take part in this research study.

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study.

Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.

To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.

To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.

To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Simultaneous CBCT Acquisition During Arc Radiotherapy	NCT02123888	Prostate Cancer Lung Cancer	Cone Beam Compu...	18 Years -	The Christie NHS Foundation Trust
CBCT-Guided Navigational Bronchoscopy For Lung Nodules	NCT04758403	Peripheral Pulm... Lung; Node Cone Beam Compu... Guided Navigati...	Navigation Bron... Cone beam compu...	18 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for cone beam computed tomography