NCT04063410

Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy

A Single-Institution, Single-Arm, Self-Controlled Trial Evaluating Perforator Phase Contrast Angiography (pPCA) as the Primary Preoperative Imaging Technique in Post-Mastectomy Breast Reconstruction Using Abdominal-Based Free Flaps

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.

Detailed description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Mammoplasty Patient

Interventions

Type	Name	Description
PROCEDURE	Angiography	Undergo standard of care CTA
PROCEDURE	MRI-Based Angiogram	Undergo pPCA
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-08-21
• Last updated: 2024-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study