MedTrace Logo

MYometrial Lesion UltrasouNd And mRi

NCT04123158 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2353

Last updated 2024-05-16

No results posted yet for this study

Summary

A monocentric prospective observational study aimed at assessing the accuracy of a diagnostic algorithm to pre-operatively identify uterine sarcomas..

Primary Aim:The primary outcome is to evaluate the accuracy (sensitivity/specificity) of "Positive Orange Criteria" category in predicting uterine sarcoma and STUMP in the population of patients with \> 3 cm myometrial lesions.

Conditions

  • Sarcoma Uterus

Interventions

DIAGNOSTIC_TEST

Ultrasound

Intervention: Diagnostic Test Ultrasound Ultrasound investigating the following characteristics: Maximum size of the lesion ≥ 8cm; Largest diameter rapid growth (Growth \>30% per year); Irregular margins of the lesion; Presence of irregular cystic areas; Absence of acoustic shadow; Color Score 4; "Cooked" aspect; \]

DIAGNOSTIC_TEST

MRI

Diagnostic Test: MRI; MRI investigating the following carachteristics: TARGET LESION Maximum diameter; Borders; Signal intensity on T2WI; Heterogeneity on T2WI; Cystic alteration(s); Cystic alteration(s) borders; Hemorrhage; T2 dark" area(s); Flow voids; Signal intensity on DWI(b-1000); ADC value; ≥ 1,23 Signal intensity on contrasted images Intensity \[relative to myometrium\] (Hyper- / Hypo- / Iso- intense) Heterogeneity (Homogeneous / Heterogeneous) Unenhanced area(s) Presence (Present / Absent) Location (Central / None or non-central) 1 Tumour - myometrium contrast ratio on T2WI \[SItumour - SImyometrium / SImyometrium\]

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesca Ciccarone, M.D. · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2023-12-04
Completion
2023-12-04

Countries

  • Italy

Study Locations

More Related Trials

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 NCT04123158 on ClinicalTrials.gov