Status:
WITHDRAWN
Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy
Lead Sponsor:
University of Cincinnati
Conditions:
Mammoplasty Patient
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 recons...
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 base...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04063410
Start Date
January 1 2023
End Date
December 31 2024
Last Update
January 18 2024
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210