Non-Contrast MRI for Perforator Flap Surgery

Not currently recruiting at 1 trial location

Overseen By Michael V Knopp, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: IUD, Activatable implants, Metallic implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using MRI scans for flap surgery, a procedure that moves tissue to cover a wound or defect. The aim is to determine if MRIs can guide this surgery effectively without contrast dye, which is often injected to enhance image clarity. The trial includes healthy volunteers to develop the imaging process and patients already scheduled for flap surgery to test it. Potential participants should be able to lie still for 30 minutes and have a flap surgery planned at Ohio State University Medical Center. Individuals with metal in their body, such as pacemakers or certain types of tattoos, are not eligible. As an unphased trial, this study allows participants to contribute to innovative imaging techniques that could improve surgical outcomes.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI protocol is safe for perforator flap surgery?

Research has shown that using MRI scans for imaging in certain surgeries is generally safe. Studies have found that MRI, particularly magnetic resonance angiography (MRA), effectively maps blood vessels without contrast dye, eliminating the risk of allergic reactions. Previous research indicates that patients tolerate MRI scans well. The procedure is non-invasive, posing no major safety concerns, as it doesn't involve surgery or entering the body. Additionally, MRI is a common imaging method in hospitals, further supporting its safety. Overall, MRI scans in this context are considered safe and have been successfully used in similar procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using non-contrast MRI for perforator flap surgery because it offers a safer and potentially more informative way to plan surgeries. Unlike traditional imaging techniques that require contrast agents, which can pose risks for certain patients, this MRI method eliminates the need for those agents, making it a safer option. Additionally, non-contrast MRI can provide detailed images of blood vessels, which are crucial for successful flap surgeries. This could lead to better surgical outcomes and fewer complications for patients.

What evidence suggests that this MRI protocol is effective for perforator flap surgery?

This trial will use non-contrast MRI to evaluate its effectiveness in planning perforator flap surgeries. Studies have shown that magnetic resonance angiography (MRA), a related imaging method, aids significantly in examining blood vessels in tissue used for breast reconstruction. This imaging method clearly reveals important arteries before surgery, crucial for planning successful procedures. Research indicates that MRA helps doctors select the best blood vessels, reducing complications. A review found that imaging like MRA can lower the risk of surgery failure. Thus, MRA is a promising tool for improving surgery outcomes. ^{1 4 6 7 8}

Who Is on the Research Team?

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults who can lie still for at least 30 minutes and are scheduled for flap surgery at OSUMC within two years. It's not suitable for those with claustrophobia, metallic implants or foreign objects in the torso, activatable implants like pacemakers, communication issues, severe auto accident history, prior perforator flap surgery, tattoos with metal ink or machinists with potential eye metal fragments.

Inclusion Criteria

I am scheduled for a flap procedure at Ohio State University Medical Center within 2 years.

I can lie on my stomach and back for at least 30 minutes.

able to provide informed consent

Exclusion Criteria

You have tattoos that may have metallic colors that cannot be removed.

I use an IUD or a medical patch for contraception.

I am able to communicate with my healthcare team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Protocol Development

Development and optimization of perforator imaging protocols with healthy volunteers

4-8 weeks

Multiple imaging sessions

Clinical Validation

Clinical validation of optimized imaging protocols with patients receiving flap surgery

2-5 years

Imaging sessions and assessments

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI Scan

Trial Overview The study tests a new MRI scan technique that doesn't use contrast agents or radiation to image blood vessels in patients needing flap surgery. The goal is to develop and validate this method by comparing it to conventional CTA images assessed by radiologists and surgeons.

How Is the Trial Designed?

Group I: Patient population Experimental Treatment 1 Intervention

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

Group II: Healthy volunteer population Experimental Treatment 1 Intervention

We plan to enroll 25 healthy volunteers.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Wright Center of Innovation in Biomedical Imaging

Collaborator

Trials

2

Recruited

40+

Citations

1. gs.amegroups.org gs.amegroups.org/article/view/8156/html

Magnetic resonance angiography in perforator flap breast ... MRA is an extremely useful preoperative imaging test for evaluation of the vasculature of donor tissue to be used in autologous breast reconstruction.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4791349/

Magnetic resonance angiography in perforator flap breast ... MRA is an extremely useful preoperative imaging test for evaluation of the vasculature of donor tissue to be used in autologous breast reconstruction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2096691125000032

Anatomical CT study of lumbar artery perforator flap in ... The LAP flap is a viable option for breast reconstruction and as a free flap in women. The L4 perforator artery is the most suitable for harvesting.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1600476/full

A systematic review and meta-analysis on computed ... Overall total flap-loss rate was 0.11% in CTA-guided cases versus 0.77% in non-CTA cases. Partial flap failure occurred in 3.4% of CTA-planned reconstructions ...

5. tprsg.com tprsg.com/assets/news/med_art-perforator_flap_magnetic_resonance_angiography.pdf

Perforator Flap Magnetic Resonance Angiography for ... Conclusion: MRA accurately maps rectus and gluteal muscle perforator arteries for preoperative planning of au- tologous flaps for breast reconstruction. Key ...

6. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2025/08000/discussion__magnetic_resonance_imaging_conditional.7.aspx

Discussion: Magnetic Resonance Imaging–Conditional ... Overall complications were similar between the groups, although the incidence of infection was significantly lower in the MRI-conditional group. Importantly, no ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/jmri.28946

MRA for Preoperative Planning and Postoperative ... Perforator flap magnetic resonance angiography (MRA) has emerged as a widely accepted and preferred modality for perforator flap mapping at several ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681517305119

Perforator mapping reduces the operative time of DIEP flap ... Recent reviews have shown that perforator mapping significantly reduces the risks of total and partial flap failure20 as well as hospital stay.21 Axial imaging ...