4D Cone Beam CT Reconstruction for Radiotherapy Via Motion Vector Optimization

NCT03551405 | Terminated DMC

• 1 other identifier: STU 082014-030
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To validate a new 4D Cone Beam CT (4DCBCT) reconstruction algorithm that was developed in our research group recently in terms of its geometry and intensity accuracy through real patient studies. Dose calculation found out in this study will not be used on the subject

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Potential Benefits:

  There is no direct benefit from the study to the subjects. All participants will be clearly informed about this. The individual patient's treatment will not be changed based on the data collected from these procedures.The study will use the CTCAE version 4.0 for reporting of acute and late adverse events related to Lung will be reported by the physician through exam/assessment during research visit, encompassing events since last research visit. Upon completion, the project will lead to an accurate and safe 4DCBCT imaging procedure for patient positioning to facilitate lung IGRT treatment.where the image quality is much improved compared to current standard 4DCBCT method and the scan time and hence radiation dose is greatly reduced.

  10 years

Secondary Outcomes (1)

• Risk/Benefit Ratio:

  10 years

Study Arms (1)

Intensity accuracy

The difference of the HU values in corresponding ROIs in the two image sets will be compared with zero using one sample t-test. In addition, we will also use these patient cases to test the computational efficiency of our algorithm. Based on our preliminary study, it is expected that the computation time will be 5\~10 sec per phase. The reconstruction time will be recorded in these patient cases and will be assessed.

Radiation: CBCT scan

Interventions

CBCT scan RADIATION

CBCT is a standard image guidance procedure for patient setup in image-guided radiation therapy at the Department of Radiation Oncology, UTSW. Our study will deliver three additional CBCT scans to each patient in only one fraction. These additional scans will increase radiation doses to the patients, which elevate the radiation-associated risks of secondary cancer.The other risk involved in this study is a possible violation of patient confidentiality. The imaging data will be completely anonymized, since the patient related information is not needed for this study.

Intensity accuracy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified by physician co-investigator during CT-simulation stage. One of the investigators or research coordinators will verbally explain the study to the patient. It will be clearly explained that patient's treatment will not be modified based on the data collected in this study. If the patient agrees to participate, an informed consent form will be signed by both the patient and the investigator/research coordinator and a copy of the signed form will be given to the patient. All of the key investigators and research coordinators in this project are experienced in clinical studies and clinical trials and have undergone appropriate protection of human research subjects training and HIPAA training.

You may qualify if:

• Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW.
• Patients are greater than 18 years of age.
• Patients understand a written informed consent document and are willing to sign the consent form.

You may not qualify if:

• Women who are pregnant or trying to get pregnant
• Children (under age of 18)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Centre

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xun Jia, PHd

  UTSW Radiation Oncology

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 11, 2018
• Study Start: November 15, 2014
• Primary Completion: April 2, 2018
• Study Completion: April 12, 2018
• Last Updated: August 20, 2020

Record last verified: 2018-06

Locations

US (1)