Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | July 2, 2012 |
| End Date: | December 31, 2021 |
| Contact: | Melanie Hughes |
| Email: | office@wcibmi.org |
| Phone: | 614-293-9998 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials