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

NCT ID: NCT03567018

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-02
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Perforator Flap Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy volunteer population

We plan to enroll 25 healthy volunteers.

Group Type: EXPERIMENTAL

MRI Scan

Intervention Type: 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).

Patient population

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

Group Type: EXPERIMENTAL

MRI Scan

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wright Center of Innovation in Biomedical Imaging

UNKNOWN

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Michael V Knopp MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael V Knopp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Martha Morehouse Medical Plaza

Columbus, Ohio, United States

The Ohio State University Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

RP0618/2012H0008

Identifier Type: -

Identifier Source: org_study_id