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Evaluation of On-Couch CBCT Image Quality

V

Varian

Status

Enrolling

Conditions

Pelvic Cancer
Abdominal Cancer
Head and Neck Cancer
Thoracic Cancer

Treatments

Device: HyperSight Imaging

Study type

Interventional

Funder types

Industry

Identifiers

NCT06576908
VAR-2023-07

Details and patient eligibility

About

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).

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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").

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

HyperSight Imaging arm
Experimental group
Description:
Subjects have both HyperSight and conventional CBCT imaging.
Treatment:
Device: HyperSight Imaging

Trial contacts and locations

1

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Central trial contact

Sean Davidson

Data sourced from clinicaltrials.gov

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