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A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality

Primary Purpose

Prostate Cancer, Head and Neck Cancers, Upper Abdomen Cancers

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Research CBCT

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Be a male or female aged 18-100.
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:

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.
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).

Sites / Locations

University of Colorado HealthRecruiting
University of Florida Health proton Therapy InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants Scanned

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in tissue visualization in CBCT images

Inter-observer similarity of delineated anatomical structures as measured by the Conformity Index (CI) similarity metrics.

Change in tissue visualization in CBCT images

Inter-observer similarity of delineated anatomical structures as measured by the Hausdorff distance (HD) similarity metrics.

Secondary Outcome Measures

Comparison of tissue delineation in CBCT images by auto-segmentation software.

Similarity of anatomical structures delineated by autosegmentation software and expert observers, as measured by CI and HD metrics.

Full Information

NCT ID

NCT04565457

First Posted

September 18, 2020

Last Updated

August 9, 2023

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04565457

Brief Title

A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality

Official Title

A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 21, 2023 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Head and Neck Cancers, Upper Abdomen Cancers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants Scanned

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Research CBCT

Intervention Description

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 Measure Information:

Title

Change in tissue visualization in CBCT images

Description

Inter-observer similarity of delineated anatomical structures as measured by the Conformity Index (CI) similarity metrics.

Time Frame

4 years

Title

Change in tissue visualization in CBCT images

Description

Inter-observer similarity of delineated anatomical structures as measured by the Hausdorff distance (HD) similarity metrics.

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Comparison of tissue delineation in CBCT images by auto-segmentation software.

Description

Similarity of anatomical structures delineated by autosegmentation software and expert observers, as measured by CI and HD metrics.

Time Frame

4 years

Other Pre-specified Outcome Measures:

Title

Concordance Correlation Coefficients

Description

Correlation of radiomics features in CBCT images and gold standard MDCT images, as measured by Concordance Correlation Coefficients (CCC).

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision to sign and date the consent form. Stated willingness to comply with all study procedures and be available for the duration of the study. Be a male or female aged 18-100. 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: 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. 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Saralina Nguyen

Phone

720-848-0691

saraline.nguyen@cuanschutz.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cem E Altunbas

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Health

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saralina Nguyen

Phone

720-848-0691

saralina.nguyen@cuanschutz.edu

Facility Name

University of Florida Health proton Therapy Institute

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32206

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Perry Johnson, PhD

pbjohnson@floridaproton.org

First Name & Middle Initial & Last Name & Degree

Perry Johnson, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality

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