Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-01-13
Brief Title:
Role of US in Uterine Fibroids in Comparison With MRI Using FIGO Classification
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Role of Ultrasound in Uterine Fibroids Characterization Compared With MRI Using FIGO Classification System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification
Detailed Description:
Uterine fibroids also known as uterine leiomyomata or myomas are the most common gynecologic tumors occurring in 20-30 of women of reproductive age and in up to 80 of all women
Leiomyomas have a wide spectrum of clinical presentations but are mostly asymptomatic Submucosal leiomyomas are more commonly associated with symptoms such as AUB dysmenorrhea infertility and recurrent pregnancy loss Subserosal leiomyomas can cause gastrointestinal or genitourinary symptoms related to size such as constipation urinary retention urinary frequency and urgency or bladder and bowel incontinence
Fibroids are monoclonal smooth muscle tumors arising from the myometrium While benign their growth is dependent on estrogen and progesterone levels and thus fibroids may enlarge with pregnancy and use of oral contraceptives and regress during menopause
Ultrasonography USG is the first-line imaging modality for any suspected structural anomaly of the female pelvis as well as the most appropriate imaging modality for abnormal uterine bleeding USG has high sensitivity and specificity in diagnosing leiomyomas but can vary with the experience of the operator performing the USG ranging from 65 to 99
Pelvic USG usually consists of a combined approach to include both transabdominal TAS and transvaginal TVUS imaging TVUS is generally considered to be more sensitive and specific with greater contrast and spatial resolution when compared to TAS TVUS is more useful in obese patients patients with a large amount of bowel gas and in patients with incomplete bladder filling all of which lower the sensitivity of TAS TAS on the other hand is helpful in females with a larger uterus that extends superiorly from the pelvis and cannot be completely visualized in the field of TVUS TAS provides an anatomic overview to better estimate overall uterine size and visualize the fundus in such cases
For incomplete visualization or indeterminate US findings MRI is recommended MR imaging is considered to be superior to USG offering anatomic detail with increased sensitivity and specificity in mapping the location and size of leiomyomas prior to treatment Previous studies have shown that MRI has the greatest advantage in diagnosing leiomyomas especially in cases of multiple leiomyomas 4 or a large volume uterus 375 mL Through the use of diffusion weighted imaging MR may also help identify lesions with higher cellularity such as leiomyosarcomas
Despite these limitations TVUS remains as efficient as MR in detecting the presence of leiomyomas and due to the lower cost greater availability and fewer contraindications USG remains the first-line imaging modality for diagnosing the presence of leiomyomas Furthermore Baird et al found that the presence of leiomyomas on a baseline ultrasound is strongly predictive of future uterine procedures approaching nearly 50 for those patients with a leiomyoma 4 cm or greater at baseline
Leiomyomas have traditionally been classified as submucosal intramural and subserosal With the advancements in the treatment modalities there was a need for a more detailed and universally accepted classification system to direct optimal treatment options For this reason the FIGO classification system was developed in 2011 for causes of AUB
The International Federation of Gynecology and Obstetrics FIGO classification system for abnormal uterine bleeding is intended to help both clinicians and researchers better categorize the causes of bleeding and plan treatments for the patient be it hysteroscopy laparoscopylaparotomy or UAE Precise classification is also necessary in the post-treatment setting in order to assess treatment response change in overall tumor burden and presence of recurrent lesions The FIGO classification system subdivides fibroids into submucosal other intramural and subserosal and hybrid types
Leiomyomas have a wide spectrum of clinical presentations but are mostly asymptomatic Submucosal leiomyomas are more commonly associated with symptoms such as AUB dysmenorrhea infertility and recurrent pregnancy loss Subserosal leiomyomas can cause gastrointestinal or genitourinary symptoms related to size such as constipation urinary retention urinary frequency and urgency or bladder and bowel incontinence
Fibroids are monoclonal smooth muscle tumors arising from the myometrium While benign their growth is dependent on estrogen and progesterone levels and thus fibroids may enlarge with pregnancy and use of oral contraceptives and regress during menopause
Ultrasonography USG is the first-line imaging modality for any suspected structural anomaly of the female pelvis as well as the most appropriate imaging modality for abnormal uterine bleeding USG has high sensitivity and specificity in diagnosing leiomyomas but can vary with the experience of the operator performing the USG ranging from 65 to 99
Pelvic USG usually consists of a combined approach to include both transabdominal TAS and transvaginal TVUS imaging TVUS is generally considered to be more sensitive and specific with greater contrast and spatial resolution when compared to TAS TVUS is more useful in obese patients patients with a large amount of bowel gas and in patients with incomplete bladder filling all of which lower the sensitivity of TAS TAS on the other hand is helpful in females with a larger uterus that extends superiorly from the pelvis and cannot be completely visualized in the field of TVUS TAS provides an anatomic overview to better estimate overall uterine size and visualize the fundus in such cases
For incomplete visualization or indeterminate US findings MRI is recommended MR imaging is considered to be superior to USG offering anatomic detail with increased sensitivity and specificity in mapping the location and size of leiomyomas prior to treatment Previous studies have shown that MRI has the greatest advantage in diagnosing leiomyomas especially in cases of multiple leiomyomas 4 or a large volume uterus 375 mL Through the use of diffusion weighted imaging MR may also help identify lesions with higher cellularity such as leiomyosarcomas
Despite these limitations TVUS remains as efficient as MR in detecting the presence of leiomyomas and due to the lower cost greater availability and fewer contraindications USG remains the first-line imaging modality for diagnosing the presence of leiomyomas Furthermore Baird et al found that the presence of leiomyomas on a baseline ultrasound is strongly predictive of future uterine procedures approaching nearly 50 for those patients with a leiomyoma 4 cm or greater at baseline
Leiomyomas have traditionally been classified as submucosal intramural and subserosal With the advancements in the treatment modalities there was a need for a more detailed and universally accepted classification system to direct optimal treatment options For this reason the FIGO classification system was developed in 2011 for causes of AUB
The International Federation of Gynecology and Obstetrics FIGO classification system for abnormal uterine bleeding is intended to help both clinicians and researchers better categorize the causes of bleeding and plan treatments for the patient be it hysteroscopy laparoscopylaparotomy or UAE Precise classification is also necessary in the post-treatment setting in order to assess treatment response change in overall tumor burden and presence of recurrent lesions The FIGO classification system subdivides fibroids into submucosal other intramural and subserosal and hybrid types
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None