Columbus, Ohio 43221

  • Perforator Flap Surgery

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

RP0618/2012H0008


NCT ID:

NCT03567018


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Michael V Knopp, MD, PhD
Principal Investigator
Ohio State University
Primary Contact:Melanie Hughes
614-293-9998
office@wcibmi.org
Backup Contact:Michael V Knopp, MD, PhD
614-293-9998
knopp.16@osu.edu

Study Dates

Start Date:July 2, 2012
Completion Date:December 31, 2021
Completion Type:Anticipated
Primary Completion Date:December 31, 2020
Primary Completion Type:Anticipated
Verification Date:November 2019
Last Changed Date:November 25, 2019
First Received Date:April 6, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Length of perforator intramuscular course
Time Frame:60 min
Safety Issues:False
Description:Location on images
Outcome Type:Secondary Outcome
Measure:Perforator size
Time Frame:60 min
Safety Issues:False
Description:Location on images
Outcome Type:Secondary Outcome
Measure:Contrast-to-noise ratio (CNR) to muscle and fat
Time Frame:Baseline
Safety Issues:False
Description:ROI based assessment
Outcome Type:Secondary Outcome
Measure:Signal-to-noise ratio (SNR)
Time Frame:Baseline
Safety Issues:False
Description:ROI based assessment
Outcome Type:Secondary Outcome
Measure:Potential Clinical Use of the MRI Images for Clinical Decision making
Time Frame:Baseline
Safety Issues:False
Description:Clinical reader assessment
Outcome Type:Secondary Outcome
Measure:Perforator branching pattern
Time Frame:60 min
Safety Issues:False
Description:Location on images
Outcome Type:Secondary Outcome
Measure:Vascular network continuity
Time Frame:60 min
Safety Issues:False
Description:Location on images
Outcome Type:Secondary Outcome
Measure:Anatomy accuracy
Time Frame:60 min
Safety Issues:False
Description:Location on images
Outcome Type:Primary Outcome
Measure:Image noise as a measure of image quality assessed by quantitative measures
Time Frame:through study completion, on average 2-5 years
Safety Issues:False
Description:assessed region of interest over target tissue and background
Outcome Type:Primary Outcome
Measure:Vessel detectability in MRI assessed by experienced readers
Time Frame:through study completion, on average 2-5 years
Safety Issues:False
Description:assessed by blinded readers
Outcome Type:Primary Outcome
Measure:Artifacts in MRI images assessed by experienced readers
Time Frame:through study completion, on average 2-5 years
Safety Issues:False
Description:assessed by blinded readers
Outcome Type:Primary Outcome
Measure:image quality
Time Frame:through study completion, on average 2-5 years
Safety Issues:False
Description:assessed by blinded readers

Study Interventions

Intervention Type:Device
Name:MRI Scan
Description: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 thoracodors
Arm Name:Healthy volunteer population

Study Arms

Study Arm Type:Experimental
Arm Name:Patient population
Description:We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.
Study Arm Type:Experimental
Arm Name:Healthy volunteer population
Description:We plan to enroll 25 healthy volunteers.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Wright Center of Innovation in Biomedical Imaging

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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