Using non-contrast MRI for planning breast reconstruction surgery
Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
This study is testing a new type of MRI without contrast dye to see if it can safely and accurately help plan breast reconstruction surgery for women who have had a mastectomy due to breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT06061835 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of non-contrast magnetic resonance angiography (MRA) for mapping perforators in deep inferior epigastric perforator flap breast reconstruction. The approach aims to eliminate radiation exposure and the risks associated with contrast agents while maintaining high accuracy in imaging. The study will involve a cohort of 100 patients who have undergone unilateral mastectomy due to breast cancer, comparing the non-contrast MRA with traditional computed tomography angiography that uses contrast. The research is conducted at two medical centers in Moscow, focusing on a specific patient population.
Who should consider this trial
Good fit: Ideal candidates are female patients who have undergone unilateral mastectomy for breast cancer and are at least one year post-radiotherapy.
Not a fit: Patients with a history of abdominal donor site free flaps, severe comorbidities, or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more cost-effective imaging option for breast reconstruction planning.
How similar studies have performed: While the use of non-contrast MRA is a novel approach, similar studies have shown promise in reducing risks associated with contrast agents in imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Moscow and 1 other locations
- Lancet Clinic — Moscow, Russian Federation (Recruiting)
- IMSechenovMMA — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Dmitry V. Melnikov, MD, PhD — I.M. Sechenov First Moscow State Medical University
- Study coordinator: Elina I. Abdeeva, MD
- Email: abdeeva_e_i@student.sechenov.ru
- Phone: +79651112189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.