Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We are closing this study as our clinical partners have all relocate from OSU and we could not find continued interest. However, we demonstrated the feasibility of this imaging approach on which we also filed a patent.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mammoplasty Patient | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Angiography | Procedure | — | UNRESOLVED |
| MRI-Based Angiogram | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (pPCA)
- description
- Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.
- interventionNames
- Procedure: Angiography
- Procedure: MRI-Based Angiogram
- Other: Quality-of-Life Assessment
Primary outcomes (4)
- measure
- Occurrence rate of surgical plan scenarios
- timeFrame
- Up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available