Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mammoplasty Patient
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Occurrence rate of surgical plan scenarios
timeFrame: Up to 2 years
measure: Acceptance rate for pPCA-based surgical plans
timeFrame: Up to 2 years
measure: Postoperative major complication rate
timeFrame: At 2 years
measure: Quality of life questionnaire (BREAST-Q)
timeFrame: Baseline up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Michael Knopp, MD
role: PRINCIPAL_INVESTIGATOR
References: