Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross Sectional Observational Study

NCT05505331 | Unknown FDA Device

• 1 other identifier: Soh-Med-22-08-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study

Conditions

Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping

Keywords

3D-Ultrasonography; MRI; Fibroid Mapping

Outcome Measures

Primary Outcomes (1)

• • The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis

  comparing the ability of 3D-ultrasonography and MRI to detect the exact location of uterine myomas

  from august 2022 to july 2023

Secondary Outcomes (1)

• • The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management

  august 2023 to july 2023

Interventions

three-Dimensional ultrasonography RADIATION

transadominal and transvaginal examination

Magnetic resonance imaging RADIATION

multiplanar T2-weighted sequences and pre-contrast T1-weighted imaging in either the sagittal or axial plane

myomectomy PROCEDURE

myoma excision

Eligibility Criteria

• Age: 12 Years - 52 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* Age group: child bearing period. * Abnormal uterine bleeding * Dysmenorrhea * Pressure symptoms * Infertility * Pregnancy loss

You may qualify if:

• Age group: child bearing period.
• Abnormal uterine bleeding
• Dysmenorrhea
• Pressure symptoms
• Infertility
• Pregnancy loss

You may not qualify if:

• The cardiac implantable electronic device (CIED)
• Metallic intraocular foreign bodies
• Implantable neurostimulation systems
• Cochlear implants/ear implant
• Drug infusion pumps
• Cerebral artery aneurysm clips
• Magnetic dental implants
• Artificial limb

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 002, Egypt

Location

Related Publications (10)

• Bulun SE. Uterine fibroids. N Engl J Med. 2013 Oct 3;369(14):1344-55. doi: 10.1056/NEJMra1209993. No abstract available.

  PMID: 24088094 BACKGROUND

• McLucas B. Diagnosis, imaging and anatomical classification of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008 Aug;22(4):627-42. doi: 10.1016/j.bpobgyn.2008.01.006. Epub 2008 Mar 7.

  PMID: 18328787 BACKGROUND

• Dueholm M, Lundorf E, Hansen ES, Ledertoug S, Olesen F. Accuracy of magnetic resonance imaging and transvaginal ultrasonography in the diagnosis, mapping, and measurement of uterine myomas. Am J Obstet Gynecol. 2002 Mar;186(3):409-15. doi: 10.1067/mob.2002.121725.

  PMID: 11904599 BACKGROUND

• Hossain MZ, Rahman MM, Ullah MM, Mukthadira M, Akter FA, Jahan AB, Jahan F. A Comparative Study of Magnetic Resonance Imaging and Transabdominal Ultrasonography for the Diagnosis and Evaluation of Uterine Fibroids. Mymensingh Med J. 2017 Oct;26(4):821-827.

  PMID: 29208870 BACKGROUND

• Murase E, Siegelman ES, Outwater EK, Perez-Jaffe LA, Tureck RW. Uterine leiomyomas: histopathologic features, MR imaging findings, differential diagnosis, and treatment. Radiographics. 1999 Sep-Oct;19(5):1179-97. doi: 10.1148/radiographics.19.5.g99se131179.

  PMID: 10489175 BACKGROUND

• Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.

  PMID: 28007752 BACKGROUND

• Salim R, Lee C, Davies A, Jolaoso B, Ofuasia E, Jurkovic D. A comparative study of three-dimensional saline infusion sonohysterography and diagnostic hysteroscopy for the classification of submucous fibroids. Hum Reprod. 2005 Jan;20(1):253-7. doi: 10.1093/humrep/deh557. Epub 2004 Oct 21.

  PMID: 15498782 BACKGROUND

• Deshmukh SP, Gonsalves CF, Guglielmo FF, Mitchell DG. Role of MR imaging of uterine leiomyomas before and after embolization. Radiographics. 2012 Oct;32(6):E251-81. doi: 10.1148/rg.326125517.

  PMID: 23065174 RESULT

• Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7. doi: 10.1067/mob.2003.99.

  PMID: 12548202 RESULT

• Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.

  PMID: 7026295 RESULT

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Uterine Myomectomy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mahmoud abdelMawjud

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)