Evaluation of On-Couch CBCT Image Quality

NCT ID: NCT06576908

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).

Detailed Description

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Conditions

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Head and Neck Cancer Thoracic Cancer Abdominal Cancer Pelvic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology in patients receiving radiation treatment for cancer.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HyperSight Imaging arm

Subjects have both HyperSight and conventional CBCT imaging.

Group Type EXPERIMENTAL

HyperSight Imaging

Intervention Type DEVICE

Subjects receive both HyperSight imaging and conventional imaging, on their first day of radiation treatment, on their second day of treatment, and on their last day of treatment.

Interventions

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HyperSight Imaging

Subjects receive both HyperSight imaging and conventional imaging, on their first day of radiation treatment, on their second day of treatment, and on their last day of treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient age is ≥ 18 years old.
* Patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus.
* A previous (standard-of-care) decision was made to treat the patient with radiation therapy using a Varian TrueBeam treatment system.
* A previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 Gy in at least 5 fractions, one fraction per day on consecutive days, Monday to Friday.
* Patient is willing and able to provide informed consent to participate in the study.

Exclusion Criteria

* Patient is pregnant or has plans for pregnancy during the period of treatment.
* 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").
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian, a Siemens Healthineers Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Margaret Cancer Centre (University Health Network)

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sean Davidson

Role: CONTACT

437-991-8294

Facility Contacts

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Michael Milosevic, MD

Role: primary

416 946 2122

Other Identifiers

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VAR-2023-07

Identifier Type: -

Identifier Source: org_study_id