CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,353 enrolled
Drug / intervention
Ultrasound +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04123158
NCT04123158N/ACompleted
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MYometrial Lesion UltrasouNd And mRi

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted Oct 10, 2019·Updated May 16, 2024

In Brief

An observational study evaluating Ultrasound and MRI for Sarcoma Uterus. Completed, enrolled 2,353 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma Uterus
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 10, 2019
Enrollment StartJan 17, 2019
Primary CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 6.7 years ago

Interventions

Ultrasoundother

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; \]

MRIother

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 \[SItumour - SImyometrium / SImyometrium\]