ACTIVE_NOT_RECRUITING

A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System

Conditions

Head and Neck Cancer Thoracic Cancer Abdominal Cancer Pelvic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cone beam computed tomography (CBCT) images are routinely used in radiation treatment delivery workflows to align patients with the treatment beam. Conventional CBCT image quality is sufficient for this task but not good enough for other radiotherapy-related tasks, such as contouring anatomical structures and calculating radiation dose distributions. HyperSight is a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam system will be used for imaging only; patients receive their radiation treatment on cleared devices and no aspect of their treatment is affected by participation in the study. HyperSight images collected during the study will be evaluated for quality and utility and compared to conventional CBCT images as well as fan beam CT images used for treatment planning.

Official Title

A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy

Quick Facts

Study Start:2023-08-29

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05975619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis. 2. Patient is at least 18 years of age. 3. If the patient will be receiving IV contrast on study, patient must have adequate renal function as defined by an estimated glomerular filtration rate (eGFR) of \>30. 4. If the patient is a woman of childbearing potential, patient must have a negative pregnancy test within 30 days of enrollment and prior to any study imaging. Contraceptive use is not an adequate documentation of no chance of pregnancy.	1. Patient is unwilling or unable to sign an IRB-approved written informed consent document. 2. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").

Inclusion Criteria

Exclusion Criteria

1. Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis.
2. Patient is at least 18 years of age.
3. If the patient will be receiving IV contrast on study, patient must have adequate renal function as defined by an estimated glomerular filtration rate (eGFR) of \>30.
4. If the patient is a woman of childbearing potential, patient must have a negative pregnancy test within 30 days of enrollment and prior to any study imaging. Contraceptive use is not an adequate documentation of no chance of pregnancy.

1. Patient is unwilling or unable to sign an IRB-approved written informed consent document.
2. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").

Contacts and Locations

Study Locations (Sites)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Varian, a Siemens Healthineers Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-29

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-08-29

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer