Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning

NCT06061835 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-09-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.

Device: MRA scan Philips Ingenia 1.5 T (Royal Philips, Netherlands) Preprocedural patient's preparation: the study was performed on an empty stomach (at least 8 hours of fasting). Type of patient positioning. MRA scanning was performed in the prone position. Additional devices. The investigators placed the patient on her abdomen on a special coordinate system mesh, for the most precise and convenient way of marking. Scanning protocol. The investigators added T2 pulse sequence to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle at TR and TE using a fat suppression program, wich allows receiving information from moving objects (including blood within the vascular lumen). Scan viewer program. OsiriX 10.0 Release

OTHER

CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.

Device: Device: Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan). Preprocedural patient's preparation: A catheter was placed in the antecubital vein of one arm, and a bolus injection of 80 ml contrast medium (Omnipaque 300 mg/ml, GE Healthcare, Oslo, Norway, registration number P N015799/01 from July 31, 2003, international nonproprietary name is a Iohexol) was administered through a power injector (M. Schilling GmbH Medical Products, Germany) at 4 ml/s. Type of patient positioning. CTA scanning was performed in the supine position. Scan viewer program. OsiriX 10.0 Release

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Dmitry V. Melnikov, MD, PhD · I.M. Sechenov First Moscow State Medical University

  • Victor A. Gombolevskiy, MD, PhD · Artificial Intelligence Research Institute (AIRI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-06
Primary Completion
2024-02-10
Completion
2024-07-30

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061835 on ClinicalTrials.gov