MYometrial Lesion UltrasouNd And mRi

NCT04123158 | Completed

• 1 other identifier: 2370
• Study Type: observational
• Target: 2,353
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultrasound; Myoma; MRI

Outcome Measures

Primary Outcomes (1)

• Diagnostic algorithm in predicting uterine sarcoma and STUMP

  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.

  January 2019- January 2024

Study Arms (3)

WHITE

If no Green Card criteria is fulfilled (Negative Green Criteria), the patient will receive an annual telephone follow up for 2 years.

Diagnostic Test: Ultrasound

GREEN

Patients will be assessed by a Green Card to check the eventual presence of at least one of the following clinical and/or ultrasound characteristics. * If one or more Green Card criteria is present (Positive Green Criteria), a dedicated clinical and ultrasound paper form will be fulfilled in order to check the presence of the criteria described in the Orange Card * In case of "negative Orange Criteria" (no Orange Card criteria, or only one Orange Card criteria, or only Orange clinical criteria) the patient will be scheduled for longitudinal follow up at 6, 12 and 24 months. At each follow-up visit, a transvaginal ultrasound examination will be performed (using the MYLUNAR Paper Form) and the patient will be re-evaluated according to the Orange Card. In case of "positive Orange Criteria" the patient will be triaged to MRI and surgery. Eventual treatment for the myometrial lesion during the study period will be recorded and the outcome of these patients will be described separately.

Diagnostic Test: Ultrasound

ORANGE

\- If at least two Orange Card criteria (including at least one ultrasound parameter) are present (Positive Orange Criteria), the patient will be examined by means of Magnetic Resonance (MRI) within 30 days and triaged to surgery (to be performed within 60 days since the enrollment in the study). A dedicated MRI paper form will be fulfilled Histology of the target myometrial lesion will be considered as the gold standard parameter.

Diagnostic Test: Ultrasound; Diagnostic Test: MRI

Interventions

Ultrasound DIAGNOSTIC_TEST

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; \]

GREEN; ORANGE; WHITE

MRI DIAGNOSTIC_TEST

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 \[SItumour - SImyometrium / SImyometrium\]

ORANGE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a myometrial lesion with the largest diameter \>3 cm that represents the target lesion

You may qualify if:

• Consecutive patients admitted to our Department for transvaginal ultrasound examination, in whom a myometrial lesion \> 3cm in size is detected.
• Informed consent form signed by the patient.

You may not qualify if:

• Patients undergoing medical treatment for myometrial lesion;
• Patients previously treated with hormonal therapy including estroprogestin in the last six months;
• Patients previously treated by embolization

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli

Rome, 00191, Italy

Location

Related Publications (5)

• Denschlag D, Thiel FC, Ackermann S, Harter P, Juhasz-Boess I, Mallmann P, Strauss HG, Ulrich U, Horn LC, Schmidt D, Vordermark D, Vogl T, Reichardt P, Gass P, Gebhardt M, Beckmann MW. Sarcoma of the Uterus. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015/074, August 2015). Geburtshilfe Frauenheilkd. 2015 Oct;75(10):1028-1042. doi: 10.1055/s-0035-1558120. Erratum In: Geburtshilfe Frauenheilkd. 2015 Oct;75(10):e3. doi: 10.1055/s-0035-1558288.

  PMID: 26640293 BACKGROUND

• Pritts EA, Vanness DJ, Berek JS, Parker W, Feinberg R, Feinberg J, Olive DL. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis. Gynecol Surg. 2015;12(3):165-177. doi: 10.1007/s10397-015-0894-4. Epub 2015 May 19.

  PMID: 26283890 BACKGROUND

• Mahnert N, Morgan D, Campbell D, Johnston C, As-Sanie S. Unexpected gynecologic malignancy diagnosed after hysterectomy performed for benign indications. Obstet Gynecol. 2015 Feb;125(2):397-405. doi: 10.1097/AOG.0000000000000642.

  PMID: 25569001 BACKGROUND

• Norris HJ, Taylor HB. Mesenchymal tumors of the uterus. I. A clinical and pathological study of 53 endometrial stromal tumors. Cancer. 1966 Jun;19(6):755-66. doi: 10.1002/1097-0142(196606)19:63.0.co;2-u. No abstract available.

  PMID: 5939046 BACKGROUND

• Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Cho KR, Chu C, Cohn D, Crispens MA, Dizon DS, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, George S, Han E, Higgins S, Huh WK, Lurain JR 3rd, Mariani A, Mutch D, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Valea FA, Yashar CM, McMillian NR, Scavone JL; National Comprehensive Cancer Network. Uterine Sarcoma, Version 1.2016: Featured Updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2015 Nov;13(11):1321-31. doi: 10.6004/jnccn.2015.0162.

  PMID: 26553763 RESULT

MeSH Terms

Conditions

Myoma

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Francesca Ciccarone, M.D.

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: January 17, 2019
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

IT (1)