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

NCT04063410 | Withdrawn DMC FDA Device

• 2 other identifiers: OSU-18094NCI-2018-03417
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammoplasty Patient

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Screening (pPCA)

EXPERIMENTAL

Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.

Procedure: Angiography; Procedure: MRI-Based Angiogram; Other: Quality-of-Life Assessment

Interventions

Angiography PROCEDURE

Undergo standard of care CTA

Screening (pPCA)

MRI-Based Angiogram PROCEDURE

Undergo pPCA

Also known as: Magnetic Resonance Angiogram, MRA

Screening (pPCA)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Screening (pPCA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Cerebral Angiography

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Michael Knopp, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)