MYometrial Lesion UltrasouNd And mRi

CompletedOBSERVATIONAL
Enrollment

2,353

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

December 4, 2023

Study Completion Date

December 4, 2023

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 \[SItumour - SImyometrium / SImyometrium\]"

Trial Locations (1)

00191

Fondazione Policlinico Agostino Gemelli, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT04123158 - MYometrial Lesion UltrasouNd And mRi | Biotech Hunter | Biotech Hunter