Clinical trial NCT01062789: Optical Breath-hold Control System for Image-guided Procedures
Official title: Use of an Optical Breath-hold Control (OBC) System for Image-guided Interventional Radiology Procedures: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Respiration
Keywords: lung biopsy
computed tomograph
respiratory motion
Controlling respiratory motion in CT guided lung biopsies
biopsy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective or our study is to test the feasibility of a new optical-based breath-hold control (OBC) system for monitoring breath-hold levels and providing patient feedback during CT-guided biopsies of the lung and upper abdomen where respiratory motion is a problem.

Detailed description: 1. Specific Aim #1: To further test the feasibility of the new OBC system for guiding accurate and reproducible breath-hold levels that correlate with internal target position in human volunteers. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to accuracy and reproducibility of a reference breath-hold level.
2. Specific Aim #2: To compare the use of 2 optical-based belts (wrapped around the chest and abdomen) versus 1 optical-based belt (wrapped around the chest or abdomen, depending on which region expands the most during respiration) with regard to accuracy and reproducibility of a pre-determined reference breath-hold level in a subset of patients (prone and/or obese). Hypothesis: The use of 2 optical-based belts allows increased accuracy and reproducibility of a pre-determined reference breath-hold level compared with the use of only one belt in this subset of patients.
3. Specific Aim #3: To test the clinical feasibility of the new OBC system in patients undergoing CT-guided biopsy of the lung or upper abdomen where respiratory motion is a problem. Hypothesis: The OBC system is as good as or better than the currently used IBC system with regard to the accuracy and reproducibility of the reference breath-hold and ease of use.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a CT-guided lung or upper abdomen biopsy (including lesions in the liver, pancreas, stomach, kidneys, adrenals, spleen, or in the peritoneum at or above the level of the kidneys) on the SMH-CT-3M scanner when either Dr. Carlson or Dr. Bender are scheduled.
* Lesions will need to measure 3 cm or less in maximum dimension and cannot be affixed to the chest or abdominal wall.

Exclusion Criteria:

* Inability to cooperate with breath-holding (including cognitive impairment, poor pulmonary function that inhibits patients from being able to hold their breath for at least 10 seconds)
* Patients with bleeding diatheses (platelets \< 50,000, International Normalized Ratio \> 1.5, or activated partial thromboplastin time \> twice normal)
* Lesions that abut the pleura or abdominal wall for a distance greater than 3 cm (these lesions were assumed to be fixed in position and less likely to be affected by respiratory motion).
* Patients with implanted medical devices (pacemakers) (this exclusion is based on the Division of Engineering Safety Review-enclosed in application)

Primary outcomes:
measure: Ability to monitor patient respiration (return of target to same anatomical position)
timeFrame: Measured daily for each individual procedure
Secondary outcomes:
measure: Needle Placement Time
timeFrame: Measured daily for each individual procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephanie K Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References: