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

Perforator Flap Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03567018
• Other study ID #: RP0618/2012H0008
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2012
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perforator Flap Surgery

Intervention

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).

Locations

Country	Name	City	State
United States	Martha Morehouse Medical Plaza	Columbus	Ohio
United States	The Ohio State University Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Wright Center of Innovation in Biomedical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	image quality	assessed by blinded readers	through study completion, on average 2-5 years
Primary	Artifacts in MRI images assessed by experienced readers	assessed by blinded readers	through study completion, on average 2-5 years
Primary	Vessel detectability in MRI assessed by experienced readers	assessed by blinded readers	through study completion, on average 2-5 years
Primary	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	Anatomy accuracy	Location on images	60 min
Secondary	Vascular network continuity	Location on images	60 min
Secondary	Perforator branching pattern	Location on images	60 min
Secondary	Potential Clinical Use of the MRI Images for Clinical Decision making	Clinical reader assessment	Baseline
Secondary	Signal-to-noise ratio (SNR)	ROI based assessment	Baseline
Secondary	Contrast-to-noise ratio (CNR) to muscle and fat	ROI based assessment	Baseline
Secondary	Perforator size	Location on images	60 min
Secondary	Length of perforator intramuscular course	Location on images	60 min