Clinical trial · Interventional

Nano-X Image Guidance: CBCT With Gravity-induced Motion

NCT04488224CI-TRIAL-00111959Nano-X IGwithdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Funding unavailable

Summary

Brief summary (as posted)

A pilot stage, device feasibility trial, to investigate the feasibility of acquiring cone beam computed tomography (CBCT) images for image guidance for radiation therapy by maintaining a fixed imaging system and rotating the participant about the horizontal axis using the Nano-X patient rotation system. It is a single-arm, controlled, single-blinded, non-treatment, non-invasive, single-institution trial.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Conventional CBCT scan	Radiation	—	UNRESOLVED
Nano-X Patient Rotation System	Device	—	UNRESOLVED
Psychometrically validated questionnaires	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Patients receiving CBCT Image Guidance during treatment
description
On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session. Participants in this arm undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. These participants do not require an additional conventional CBCT as the SOC conventional CBCT images are used to benchmark the experimental Nano-X CBCT scans for evaluation of the primary outcome measure.
interventionNames
1. Device: Nano-X Patient Rotation System
2. Other: Psychometrically validated questionnaires
type
EXPERIMENTAL
label
Patients not receiving CBCT Image Guidance during treatment
description
On two separate occasions, CBCT images will be acquired while participants are rotated 360° about the horizontal axis on the Nano-X Patient Rotation System. The rotation will take approximately 72 seconds to complete. Psychometrically validated questionnaires will be completed by the participant before and after each Nano-X CBCT session. Participants in this arm do not undergo conventional CBCT for image guidance during standard of care (SOC) radiotherapy treatment. As such these participants will receive an additional conventional CBCT scan on standard equipment which used to benchmark the experimental NAno-X CBCT scans for evaluation of the primary outcome measure.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Cancer patients that are receiving radiation therapy that are able to be imaged with the Nano-X PRS with one of the following tumour sites:

   1. in the head/neck region
   2. in the chest/abdomen/pelvic region with fast CBCT used for standard of care image guidance and is aged 60 years or older
   3. in the chest/abdomen/pelvic region not receiving CBCT for standard of care image guidance and is aged 70 years or older
   4. diagnosis of lung cancer with stage II-IV
2. ≥18 years of age
3. ECOG Performance Status 0-2
4. Must be able to communicate fluently in English to:

   i. Receive instructions from operators of the PRS for safety entering and leaving the Patient Rotation System and required conduct during the during the rotation session, and ii. Communicate their level of comfort or distress to operators of the equipment.
5. Signed, written informed consent or approved alternative, non-contact method for informed consent.

Exclusion Criteria:

1. Pregnant women
2. Patients for whom attaining informed consent would not be possible, including mentally impairment
3. Patients with severe vertigo or recent a diagnosis of Benign Paroxysmal Positioning Vertigo.

References

Publications (1)

DERIVEDDebrot E, Liu P, Gardner M, Heng SM, Chan CH, Corde S, Downes S, Jackson M, Keall P. Nano X Image Guidance in radiation therapy: feasibility study protocol for cone beam computed tomography imaging with gravity-induced motion. Pilot Feasibility Stud. 2023 Jun 13;9(1):95. doi: 10.1186/s40814-023-01340-z. PMID 37312127