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Non-Contrast MRI for Perforator Flap Surgery

N/A
Waitlist Available
Led By Michael V Knopp, MD, PhD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
the clinical patients need to have a flap procedure scheduled at the Ohio State University Medical Center within the next 24 months
able to lie in both prone and supine positions for at least 30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average 2-5 years
Awards & highlights

Study Summary

This trial is testing a new way to image perforators without using an injected contrast agent. They will compare the results to existing images to see if it is effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since no contrast agent is used and there's no ionizing radiation involved in the MRI scans being tested, risks are minimal but may include discomfort from lying still and anxiety related to being in a confined space during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a flap procedure at Ohio State University Medical Center within 2 years.
Select...
I can lie on my stomach and back for at least 30 minutes.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average 2-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average 2-5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Artifacts in MRI images assessed by experienced readers
Image noise as a measure of image quality assessed by quantitative measures
Vessel detectability in MRI assessed by experienced readers
+1 more
Secondary outcome measures
Anatomy accuracy
Contrast-to-noise ratio (CNR) to muscle and fat
Length of perforator intramuscular course
+5 more

Side effects data

From 2021 Phase 2 trial • 7 Patients • NCT01585402
100%
Diarrhea
71%
Nausea
71%
Myalgia
71%
Fatigue
71%
Arthralgia
57%
Hypernatremia
57%
Vomiting
43%
Headache
43%
Anemia
43%
Dizziness
43%
Dysgeusia
43%
Hypertriglyceridemia
43%
Palpitations
43%
Sinus bradycardia
43%
Back pain
43%
Flu like symptoms
29%
Skin infection
29%
Abdominal pain
29%
Bloating
29%
Constipation
29%
Dental caries
29%
Gastroesophageal reflux disease
29%
Cholesterol high
29%
Anxiety
29%
Upper respiratory infection
29%
Paresthesia
29%
Anorexia
29%
Neck pain
29%
Dyspepsia
29%
Alanine aminotransferase increased
29%
Weight gain
29%
Weight loss
29%
Bone pain
29%
Rash maculo-papular
29%
Hematuria
29%
Hypertension
14%
Esophagitis
14%
Gastritis
14%
Stroke
14%
Lung infection
14%
Urinary tract infection
14%
External iliac artery stenosis
14%
Jump graft on the bypass area declining function of previous graft
14%
Dry mouth
14%
Dysphagia
14%
Periodontal disease
14%
Toothache
14%
Hypercalcemia
14%
Hyperkalemia
14%
Depression
14%
Vivid dreams
14%
Sore throat
14%
Creatinine increased
14%
Lymphocyte count decreased
14%
Calcaneus spur
14%
Joint inflammation/pain
14%
Osteoporosis
14%
Pain in extremity
14%
Pelvic pain
14%
Cold symptoms
14%
Strep agalactiae Urinary tract infection
14%
Malaise
14%
Memory impairment
14%
Syncope
14%
Elevated urine phosphorus
14%
Renal calculi
14%
Urinary frequency
14%
Arthralgia flare swelling of right hand
14%
Arthralgia flare swelling of right wrist
14%
Swelling of finger on fourth MCP of right hand
14%
Non-cardiac chest pain
14%
Pain
14%
Streptococcus pyogenes
14%
Premature atrial contractions
14%
Chest pain - cardiac
14%
Cough
14%
Dyspnea
14%
Postnasal drip
14%
White blood cell decreased
14%
Flank pain
14%
Ear pain
14%
Presyncope
14%
Somnolence
14%
Edema limbs
14%
Left inguinal hernia surgery
14%
Hemorrhoids
14%
Injection site reaction
14%
Lower gastrointestinal hemorrhage
14%
Hypocalcemia
14%
Hypercholesterolemia
14%
Hyperphosphatemia
14%
Left atrial enlargement; Incomplete right bundle branch block
14%
Sinus tachycardia
14%
Allergic reaction
14%
Aspartate aminotransferase increased
14%
Fracture
14%
Pain of skin
14%
Blister on right 4th toe
14%
Dry eye
14%
Laryngitis
14%
Hemoglobinuria
14%
Skin ulceration
14%
Hyperparathyroidism
14%
Hypotension
14%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient populationExperimental Treatment1 Intervention
We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.
Group II: Healthy volunteer populationExperimental Treatment1 Intervention
We plan to enroll 25 healthy volunteers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI Scan
2012
Completed Phase 2
~1420

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,348 Total Patients Enrolled
Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
501,097 Total Patients Enrolled
Wright Center of Innovation in Biomedical ImagingUNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

MRI Scan Clinical Trial Eligibility Overview. Trial Name: NCT03567018 — N/A
Perforator Flap Surgery Research Study Groups: Healthy volunteer population, Patient population
Perforator Flap Surgery Clinical Trial 2023: MRI Scan Highlights & Side Effects. Trial Name: NCT03567018 — N/A
MRI Scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT03567018 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary objectives have been outlined for this research endeavor?

"This controlled clinical trial, likely to last between two and five years, will track the detectability of vessels via MRI as determined by experienced readers. Secondary aims include tracking length of perforator intramuscular course (location on images), potential utility of MRI for decision-making (clinical reader assessment), and accuracy in anatomical location (location on images)."

Answered by AI

What is the current population of participants in this investigation?

"Affirmative, the information accessible on clinicaltrials.gov proves that this scientific investigation is currently searching for participants. This experiment was initially posted on July 2nd 2012 and its most recent update occurred April 15th 2022. Altogether, it requires 75 volunteers from two treatment centres to participate."

Answered by AI

Are new participants being accepted for this experimental protocol?

"Affirmative. According to clinicaltrials.gov, this trial was first advertised on July 2nd 2012 and has been recently updated as of April 15th 2022. There is need for 75 enrollees across two medical sites."

Answered by AI
~1 spots leftby Dec 2024