Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients with Breast Cancer Undergoing Breast Reconstruction with Free-Flap Methods After Mastectomy
- Subject must weigh =< 350 lbs.
- Subject must be scheduled to receive uni- or bilateral breast reconstruction using one of the abdominal-based free flap techniques (deep inferior epigastric perforator [DIEP] flap, superficial inferior epigastric artery [SIEA] flap, or free-transverse rectus abdominis musculocutaneous [TRAM] flap) within the next 12 months.
- Subject must have received, or be scheduled to receive at least one preoperative CTA prior to the surgery.
- Subject must be able to lie in both prone and supine positions for at least 30 minutes.
- Subjects who are determined to be incompatible for MRI based on local policy.
- Subjects with previous history of abdominal-based free flap surgery.
- Severe anxiety or claustrophobia that would prohibit the required study procedures from being conducted.
- Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with the subject’s safety, the informed consent procedure, or compliance to the study protocol, in the opinion of the investigator.
I. To assess the quality of surgical plans prepared under the guidance of the non-contrast, ionizing-radiation-free perforator phase contrast angiography (pPCA) against plans based upon the current gold standard, the X-ray-based, contrast-enhanced computed tomographic angiography (CTA).
I. To assess whether pPCA is more accurate than CTA for vessel size measurement.
II. To assess the impact of pPCA-based surgical planning on the clinical outcomes of abdominal-based free flap surgery.
III. To obtain and analyze cost/expenditure information for pPCA-guided abdominal-based free flap procedures.
Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.
After surgery, patients will be followed up at 24 hours, 1 week, 3 months, 1 year and 2 years.
Trial Phase Phase II
Trial Type Screening
Ohio State University Comprehensive Cancer Center
Michael Vinzenz Knopp
- Primary ID OSU-18094
- Secondary IDs NCI-2018-03417, 2019C0002
- Clinicaltrials.gov ID NCT04063410