Non-Contrast MRI for Perforator Flap Surgery

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

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

You work with metal and machinery and may have metal fragments in or near your eyes.

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+