Clinical trial · Interventional
Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning
Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure, minimize the risk of potentially harmful effects of contrast agents, and reduce the cost of the study.The investigators assume that the use of non-contrast MRA following our protocol including certain patient's positioning, a special pulse scanning sequence and perforators' projection method is effective and allows mapping of perforators without injecting a potential harmful contrast agent.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Postsurgical Acquired Absence of Organ | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. | Other | — | UNRESOLVED |
| Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Non-contrast MRA (MRA "-")
- description
- Participants in this group underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an enhanced protocol that eliminates the use of potentially hazardous contrast agent and radiation exposure while providing high accuracy of visualization.
- interventionNames
- Other: Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.
- type
- OTHER
- label
- CTA with contrast (CTA "+")
- description
- Control group. Participants in this group underwent preoperative planning using the standard commonly used method - computed tomography angiography (CTA) with IV (intravenous) iodine-containing contrast injection.
- interventionNames
- Other: CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * A female patients who underwent unilateral mastectomy due to breast cancer, in remission. * At least 1 year after completion of radiotherapy. Non-inclusion Criteria: * A history of abdominal donor site free flaps or abdominoplasty. * Inability to give consent. * The expander with magnetic ports, claustrophobia, pregnancy and breastfeeding. * Patients with severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes * The presence of psychiatric illness preventing participation in the study. Exclusion Criteria: * Patient's pregnancy diagnosed during the research period. * Patient's refusal of surgery, patient's refusal of further participation in the study. * The presence of concomitant diseases preventing participation in the study.
References
Publications (0)
Data not yet available