Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Re… (NCT06061835) | Clinical Trial Compass
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Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning
Russia135 participantsStarted 2023-05-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The concordance ratio.
Timeframe: During the surgery.
2
The overall operation time (min).
Timeframe: Immediately after the surgery.
3
The time of the pedicle cut (min).
Timeframe: During the surgery.
4
The length of the fascia incision (cm).
Timeframe: During the surgery.
5
Intraoperative evaluation of flap perfusion.
Timeframe: During the surgery.
6
Postoperative flap necrosis (%).
Timeframe: During the first week after surgery.
Trial details
NCT IDNCT06061835
SponsorI.M. Sechenov First Moscow State Medical University