Prostate Cancer Clinical Trial

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

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.

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Full 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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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).

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

40

Study ID:

NCT04565457

Recruitment Status:

Suspended

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado Health
Aurora Colorado, 80045, United States

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Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

40

Study ID:

NCT04565457

Recruitment Status:

Suspended

Sponsor:


University of Colorado, Denver

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