A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04565457|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment|
|Prostate Cancer Head and Neck Cancers Upper Abdomen Cancers||Device: Research CBCT|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||September 2025|
All participants will be scanned with a CBCT system equipped with 2D antiscatter grid technology, referred to as research CBCT. Each participant will also be scanned with a standard clinical CBCT as part of their standard clinical care, which will serve as the baseline, or control.
Device: Research CBCT
Each study participant will receive one additional CBCT scan, with 2D antiscatter grid in place. This is the only intervention in the study, referred as research CBCT scan, and it will be performed on one of the days during the participant's radiation treatment course. This additional research CBCT scan will be used strictly for the objectives of this study. It will not be used as part of the standard clinical care, such as imaging guidance of participant's radiation treatment or diagnostic purposes. To deliver participant's radiation treatment under CBCT guidance, a standard clinical CBCT scan will be acquired, as in standard clinical care protocols.
- Change in tissue visualization in CBCT images [ Time Frame: 4 years ]Inter-observer similarity of delineated anatomical structures as measured by the Conformity Index (CI) similarity metrics.
- Change in tissue visualization in CBCT images [ Time Frame: 4 years ]Inter-observer similarity of delineated anatomical structures as measured by the Hausdorff distance (HD) similarity metrics.
- Comparison of tissue delineation in CBCT images by auto-segmentation software. [ Time Frame: 4 years ]Similarity of anatomical structures delineated by autosegmentation software and expert observers, as measured by CI and HD metrics.
- Concordance Correlation Coefficients [ Time Frame: 4 years ]Correlation of radiomics features in CBCT images and gold standard MDCT images, as measured by Concordance Correlation Coefficients (CCC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565457
|Contact: Anne Martinfirstname.lastname@example.org|