ACTIVE_NOT_RECRUITING

Evaluation of Improved Onboard Patient Imaging

Conditions

Head and Neck Cancer Breast Cancer Upper Gastrointestinal Cancer Lung Cancer Pelvic Cancer CBCT

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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

The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.

Official Title

Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1

Quick Facts

Study Start:2024-07-10

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06187103

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 willing and able to provide written consent. 2. Patient is at least 18 years of age at the time of consent. 3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis. 4. Patient has ECOG performance status 0-2. 5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.	1. Patient is pregnant or attempting pregnancy. 2. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni). 3. Patient receives palliative radiation for 5 or fewer fractions. 4. 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"). This includes prisoners.

Inclusion Criteria

Exclusion Criteria

1. Patient is willing and able to provide written consent.
2. Patient is at least 18 years of age at the time of consent.
3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
4. Patient has ECOG performance status 0-2.
5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.

1. Patient is pregnant or attempting pregnancy.
2. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
3. Patient receives palliative radiation for 5 or fewer fractions.
4. 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"). This includes prisoners.

Contacts and Locations

Study Locations (Sites)

University of Maryland Medical Center

Baltimore, Maryland, 21201-1544

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 Date2024-07-10

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-07-10

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

CBCT

Additional Relevant MeSH Terms

Head and Neck Cancer
Breast Cancer
Upper Gastrointestinal Cancer
Lung Cancer
Pelvic Cancer