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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mammoplasty Patient
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Angiography; Procedure: MRI-Based Angiogram

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening (pPCA); Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Angiography; Undergo standard of care CTA; Procedure: MRI-Based Angiogram; Undergo pPCA; Other Names: MRA; Magnetic Resonance Angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence rate of surgical plan scenarios	When all participating plastic surgeons reach a consensus decision on the final surgical plan after jointly reviewing the perforator phase contrast angiography (pPCA)-based and contrast-enhanced computed (CTA) based preliminary plans, one of four scenarios may occur: I. The pPCA-based and CTA-based plans are identical. Both are accepted as the final plan; II. There is substantial discrepancy between the two preliminary plans. The pPCA-based plan is eventually accepted as the final plan; III. There is substantial discrepancy between the two preliminary plans. The CTA-based plan is eventually accepted as the final plan; IV. There is substantial discrepancy between the two preliminary plans, but neither the pPCA-based plan nor the CTA-based plan is deemed acceptable. The final plan is proposed based upon comprehensive assessment of both image sets. The occurrence rate of scenario I-IV cases will be estimated with 95% confidence interval, respectively.	Up to 2 years
Acceptance rate for pPCA-based surgical plans	The acceptance rate for pPCA-based plans will be evaluated using one-sided non-inferiority test of correlated proportions with non-inferiority margin of 15%. Perforator size measurements obtained with pPCA or CTA will be summarized separately, and be compared between pPCA and CTA using paired t-test.	Up to 2 years
Postoperative major complication rate	Will be calculated and exact binomial 95% confidence interval will be provided. The calculated major complication rate will be compared with historical data. The association of complications with demographic and clinical characteristics (e.g., age, obesity, laterality and radiation) will be explored using two sample t-test or Wilcoxon test for continuous variables, and chi-square test or Fisher?s exact test for categorical variables. Logistic regression model will also be used to study the association between the complications and the pPCA/CTA-based plans, controlling those significant confounders.	At 2 years
Quality of life questionnaire (BREAST-Q)	Patient reported outcome for breast reconstruction questionnaire (BREAST-Q) score for satisfaction with breast will be summarized using descriptive statistics (mean and standard deviation) at baseline, 1 year postoperative, 2 years postoperative, as well as the change from baseline to postoperative. BREAST-Q score at 2 years will be compared with historical data.	Baseline up to 2 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Michael Knopp, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OSU-18094; NCI-2018-03417 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes