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

NCT03567018 | Unknown FDA Device

• 1 other identifier: RP0618/2012H0008
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Perforator Flap Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Anatomy accuracy

  60 min

• Vascular network continuity

  60 min

• Perforator branching pattern

  60 min

• Potential Clinical Use of the MRI Images for Clinical Decision making

  Baseline

• Signal-to-noise ratio (SNR)

  Baseline

Study Arms (2)

Healthy volunteer population

EXPERIMENTAL

We plan to enroll 25 healthy volunteers.

Device: MRI Scan

Patient population

EXPERIMENTAL

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

Device: MRI Scan

Interventions

MRI Scan DEVICE

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).

Healthy volunteer population; Patient population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Wright Center of Innovation in Biomedical Imaging: collaborator

Study Sites (2)

Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

The Ohio State University Hospital

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael V Knopp, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two populations are being investigated in this trial; a healthy volunteer population and a patient population. Each population will receive an MRI scan.

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: June 25, 2018
• Study Start: July 2, 2012
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (2)