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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This is Pilot study that investigates the CBCT(Cone beam computed tomography) image quality improvement provided by the 2D antiscatter grid technology. The primary objective is to assess the improvement in tissue visualization in an observer study, which will be conducted in a blinded fashion.

Condition or disease Intervention/treatment
Prostate Cancer Head and Neck Cancers Upper Abdomen Cancers Device: Research CBCT

Detailed Description:
This is a single arm study, where 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. Thus, the image quality improvement in research CBCT will assessed with respect to standard clinical CBCT.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants Scanned
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Thirty participants will be accrued from patients who receive radiation therapy for head and neck, prostate, and upper abdomen cancers (10 patients from Groups 1-3). These participants will be selected from a patient population treated with megavoltage photon therapy.

The impact of 2D grid on CBCT image quality may be different in photon and proton therapy. Therefore, 10 prostate cancer patients, who are treated with proton therapy and imaged with proton therapy-specific CBCT systems, will also be accrued (Group 4).

In summary, a total of forty patients will be enrolled in this study, who receive CBCT-guided photon or proton therapy.

Criteria

Inclusion Criteria:

  1. Provision to sign and date the consent form.
  2. Stated willingness to comply with all study procedures and be available for the duration of the study.
  3. Be a male or female aged 18-100.
  4. Participants who will be treated with CBCT-guided photon therapy for upper abdomen, prostate, head and neck cancers, or with CBCT-guided proton therapy for prostate cancer.

Exclusion Criteria:

  1. Metallic implants in the CBCT scan volume, such as hip prostheses or spine stabilization hardware. Dental implants, filings, or fiducial markers may be acceptable, and the decision for inclusion/exclusion will be on a case-by-case basis, by reviewing prior CT images of the study candidate. Patient's prior CT images will be reviewed by the PI. Patients who do not have the ability to lie still for the duration of his/her CBCT imaging and treatment should be excluded. If image artifacts in prior scans are deemed excessive, patient will be excluded from the study.
  2. Known pregnancy. (Per SOC, a pregnancy test will be performed prior to CBCT scan on Day 1. At this time, women of child-bearing potential will receive a pregnancy test to reconfirm eligibility).

Information from the National Library of Medicine

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


Contacts
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Contact: Anne Martin 720-848-0657 anne.c.martin@cuanschutz.edu

Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04565457    
Other Study ID Numbers: 20-1684.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms