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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perforator Flap Surgery
• Intervention / Treatment: Device: MRI Scan

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Martha Morehouse Medical Plaza
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteer population; We plan to enroll 25 healthy volunteers.	Device: MRI Scan; Study participants will be scanned with a 3.0 Tesla Phillips Ingenia CX whole body clinical MRI system located at the Wright Center of Innovation at The Ohio State University Medical Center. Anatomical and angiographic MR images will be acquired for one of the most commonly used flap surgery donor perforators including but not limited to: the deep inferior epigastric perforators (DIEP); the superior gluteal arter perforators (SGAP); the inferior gluteal artery perforators (IGAP); the thoracodorsal artery perforators (TDAP); the anterolateral thigh perforators (ATL).
Experimental: Patient population; We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.	Device: MRI Scan; Study participants will be scanned with a 3.0 Tesla Phillips Ingenia CX whole body clinical MRI system located at the Wright Center of Innovation at The Ohio State University Medical Center. Anatomical and angiographic MR images will be acquired for one of the most commonly used flap surgery donor perforators including but not limited to: the deep inferior epigastric perforators (DIEP); the superior gluteal arter perforators (SGAP); the inferior gluteal artery perforators (IGAP); the thoracodorsal artery perforators (TDAP); the anterolateral thigh perforators (ATL).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Wright Center of Innovation in Biomedical Imaging
• Investigators: Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2012
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RP0618/2012H0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes