Perforator Flap SurgeryNCT03567018
Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
A study testing MRI Scan in people with Perforator Flap Surgery, run by University of Cincinnati at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perforator Flap Surgery
- What is being tested?
- MRI Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2012to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- subjects with previous history of perforator flap surgery
- subjects who cannot communicate with the researcher for any reason
- claustrophobia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
The Ohio State University Hospital
Columbus, Ohio, 43221
About this study
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.
Read the 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
- Being tested
- MRI Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer population | Experimental | We plan to enroll 25 healthy volunteers. Receives: Device: MRI Scan |
| Patient population | Experimental | We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center. Receives: Device: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
image quality
assessed by blinded readers
Measured: through study completion, on average 2-5 years
Artifacts in MRI images assessed by experienced readers
assessed by blinded readers
Measured: through study completion, on average 2-5 years
Vessel detectability in MRI assessed by experienced readers
assessed by blinded readers
Measured: 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
Measured: through study completion, on average 2-5 years
Secondary outcomes (8)
Anatomy accuracy
Location on images
Measured: 60 min
Vascular network continuity
Location on images
Measured: 60 min
Perforator branching pattern
Location on images
Measured: 60 min
Potential Clinical Use of the MRI Images for Clinical Decision making
Clinical reader assessment
Measured: Baseline
Signal-to-noise ratio (SNR)
ROI based assessment
Measured: Baseline
Contrast-to-noise ratio (CNR) to muscle and fat
ROI based assessment
Measured: Baseline
Perforator size
Location on images
Measured: 60 min
Length of perforator intramuscular course
Location on images
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start2 Jul 2012
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforator Flap SurgeryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two populations are being investigated in this trial; a healthy volunteer population and a patient population. Each population will receive an MRI scan.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Wright Center of Innovation in Biomedical Imaging
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael V Knopp, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567018
- Sponsor's protocol ID
- RP0618/2012H0008
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2018
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
- ClinicalTrials.gov ID
- NCT03567018
- Acronym / sponsor ID
- RP0618/2012H0008
- Conditions
- Perforator Flap Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Wright Center of Innovation in Biomedical Imaging
- Study start
- 2 Jul 2012 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two populations are being investigated in this trial; a healthy volunteer population and a patient population. Each population will receive an MRI scan.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer population | Experimental | Device: MRI ScanWe plan to enroll 25 healthy volunteers. |
| Patient population | Experimental | Device: MRI ScanWe plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ScanStudy 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). | Device | Healthy volunteer population, Patient population |
Primary outcome
image quality
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
Artifacts in MRI images assessed by experienced readers
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
Vessel detectability in MRI assessed by experienced readers
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
Image noise as a measure of image quality assessed by quantitative measures
Time frame: through study completion, on average 2-5 years
assessed region of interest over target tissue and background
8 secondary outcomes
Anatomy accuracy
Time frame: 60 min
Vascular network continuity
Time frame: 60 min
Perforator branching pattern
Time frame: 60 min
Potential Clinical Use of the MRI Images for Clinical Decision making
Time frame: Baseline
Signal-to-noise ratio (SNR)
Time frame: Baseline
Contrast-to-noise ratio (CNR) to muscle and fat
Time frame: Baseline
Perforator size
Time frame: 60 min
Length of perforator intramuscular course
Time frame: 60 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael V Knopp, MD, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan in people with Perforator Flap Surgery, run by University of Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
image quality (time frame: through study completion, on average 2-5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.