Clinical trial NCT03567018: Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
Official title: Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perforator Flap Surgery
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Wright Center of Innovation in Biomedical Imaging
First posted: 2018-06-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two populations are being investigated in this trial; a healthy volunteer population and a patient population. Each population will receive an MRI scan.
Primary purpose: TREATMENT

Brief summary: In this study the investigators plan to enroll a total of 25 evaluable volunteers (volunteer population) for the development and optimization of perforator imaging protocols and 50 evaluable clinical patients receiving flap procedures at OSUMC for the clinical validation of the optimized protocol. No extrinsic MR contrast agent will be injected. Clinical patients' MRI images will be evaluated independently by radiologists and plastic surgeons and compared to the clinical CTA images.

Detailed description: The overall objective of this pilot study is to develop and optimize preoperative MRA imaging protocols for various perforators commonly used in flap surgery with phantoms and healthy volunteers and to obtain clinical validation of the optimized protocols with a group of patients receiving flap surgery at The OSU Wexmer Medical Center. Data obtained in this study may also serve as the basis for statistical planning of future clinical trials. Based on previous experience with other magnetic resonance imaging (MRI) techniques, the investigators hypothesize that optimal MRA images can only be obtained with a carefully selected combination of imaging hardware, acquisition, and postprocessing factors. The main objective of this pilot study is to determine this optimal combination through the comparison of image between different combinations. The secondary objective of this pilot study is to evaluate, both qualitatively and quantitatively, the quality of the optimized MRA images and compare them with clinical CTA images. The primary hypothesis is that the quality of the optimized MRA images is at least comparable to that of the CTA images. The quantitative measurements obtained from this pilot population will also serve as the preliminary data for future studies and be used in statistical calculations that determine their study population.

Eligibility criteria: Inclusion Criteria:

* greater than or equal to 18 years at time of enrollment
* able to provide informed consent
* able to lie in both prone and supine positions for at least 30 minutes
* the clinical patients need to have a flap procedure scheduled at the Ohio State University Medical Center within the next 24 months

Exclusion Criteria:

* Use of an IUD (intrauterine device) or medical patch
* Subjects with any type of activatable implants (e.g. cardiac pacemakers, deep brain stimulators, spinal cord stimulators, cochlear implants, electronic infusion pumps, etc.)
* Subjects with any type of metallic implants or foreign objects in torso region (e.g. cardiac stents, surgical clips, shrapnel fragments from war wounds, etc.)
* metal works and machinists (who may have metallic fragments in or near the eyes)
* severe auto accident victims
* subjects with permanent tattoos that may contain metallic coloring
* subjects with previous history of perforator flap surgery
* subjects who cannot communicate with the researcher for any reason
* claustrophobia

Primary outcomes:
measure: image quality
timeFrame: through study completion, on average 2-5 years
measure: Artifacts in MRI images assessed by experienced readers
timeFrame: through study completion, on average 2-5 years
measure: Vessel detectability in MRI assessed by experienced readers
timeFrame: through study completion, on average 2-5 years
measure: Image noise as a measure of image quality assessed by quantitative measures
timeFrame: through study completion, on average 2-5 years
Secondary outcomes:
measure: Anatomy accuracy
timeFrame: 60 min
measure: Vascular network continuity
timeFrame: 60 min
measure: Perforator branching pattern
timeFrame: 60 min
measure: Potential Clinical Use of the MRI Images for Clinical Decision making
timeFrame: Baseline
measure: Signal-to-noise ratio (SNR)
timeFrame: Baseline
measure: Contrast-to-noise ratio (CNR) to muscle and fat
timeFrame: Baseline
measure: Perforator size
timeFrame: 60 min
measure: Length of perforator intramuscular course
timeFrame: 60 min
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael V Knopp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: