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

University of Cincinnati

Status: Active, not recruiting

Conditions: Perforator Flap Surgery

Treatments: Device: MRI Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03567018

RP0618/2012H0008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Healthy volunteer population

Experimental group

Description:

We plan to enroll 25 healthy volunteers.

Treatment:

Device: MRI Scan

Patient population

Experimental group

Description:

We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.

Treatment:

Device: MRI Scan