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Trial Title:
Evaluation of On-Couch CBCT Image Quality
NCT ID:
NCT06576908
Condition:
Head and Neck Cancer
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer
Conditions: Official terms:
Pelvic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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 purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
HyperSight Imaging
Description:
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.
Arm group label:
HyperSight Imaging arm
Summary:
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).
Criteria for eligibility:
Criteria:
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").
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Centre (University Health Network)
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Contact:
Last name:
Michael Milosevic, MD
Phone:
416 946 2122
Email:
Mike.Milosevic@uhn.ca
Investigator:
Last name:
Michael Milosevic, MD
Email:
Principal Investigator
Start date:
August 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Varian, a Siemens Healthineers Company
Agency class:
Industry
Source:
Varian, a Siemens Healthineers Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06576908
