Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography

Not Applicable

Active, not recruiting

• Conditions: Perforator Flap Surgery
• Interventions: Device: MRI Scan

• Registration Number: NCT03567018
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2012-07-02
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient population	MRI Scan	We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.
Healthy volunteer population	MRI Scan	We plan to enroll 25 healthy volunteers.

Primary Outcome Measures

Name	Time	Method
image quality	through study completion, on average 2-5 years	assessed by blinded readers
Vessel detectability in MRI assessed by experienced readers	through study completion, on average 2-5 years	assessed by blinded readers
Artifacts in MRI images assessed by experienced readers	through study completion, on average 2-5 years	assessed by blinded readers
Image noise as a measure of image quality assessed by quantitative measures	through study completion, on average 2-5 years	assessed region of interest over target tissue and background

Secondary Outcome Measures

Name	Time	Method
Contrast-to-noise ratio (CNR) to muscle and fat	Baseline	ROI based assessment
Perforator branching pattern	60 min	Location on images
Anatomy accuracy	60 min	Location on images
Vascular network continuity	60 min	Location on images
Potential Clinical Use of the MRI Images for Clinical Decision making	Baseline	Clinical reader assessment
Perforator size	60 min	Location on images
Signal-to-noise ratio (SNR)	Baseline	ROI based assessment
Length of perforator intramuscular course	60 min	Location on images

Trial Locations

Locations (2)

The Ohio State University Hospital; 🇺🇸 Columbus, Ohio, United States

Martha Morehouse Medical Plaza; 🇺🇸 Columbus, Ohio, United States