NCT02820532

Brief Summary

Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate for this uncertainty. However it is not known if the couch motion influences the respiratory pattern of the patients. This will be evaluated in this study on healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

June 20, 2016

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory amplitude

    Change of respiratory motion due to couch motion. Respiration will be measured on the chest wall using a contact-free measurement.

    baseline and 20 min

Secondary Outcomes (5)

  • Heart beat

    baseline and 20 min

  • Skin humidity

    baseline and 20 min

  • Pupil motion

    baseline and 20 min

  • Body motion

    baseline and 20 min

  • Motion sickness

    baseline and 20 min

Study Arms (1)

Tracking

OTHER

The volunteers will be placed on the treatment couch. Their respiratory motion will be measured and the treatment couch will be moved accordingly. During the couch motion experiment the heartbeat, the skin humidity, the respiratory characteristics and the pupil motion will be additionally measured.

Device: Protura Treatment table

Interventions

The treatment couch will be moved according to the respiratory motion of the patient. As a reference first the respiration will be measured without couch motion, than the couch will be switched on and we will evaluate if the respiration changes due to the motion of the couch. This procedure will be repeated once.

Tracking

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Male and Female subjects
  • ≥18 and ≤100 years
  • Written informed consent by the participant after information about the project
  • German speaking

You may not qualify if:

  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Body weight exceeding 200kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Body motion during dynamic couch tracking with healthy volunteers. Phys Med Biol. 2018 Dec 19;64(1):015001. doi: 10.1088/1361-6560/aaf361.

  • Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Unconscious physiological response of healthy volunteers to dynamic respiration-synchronized couch motion. Radiat Oncol. 2017 Nov 28;12(1):189. doi: 10.1186/s13014-017-0925-6.

Study Officials

  • Matthias Guckenberger, MD

    University Hospital Zurich, Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 1, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations