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MYometrial Lesion UltrasouNd And mRi (MYLUNAR)

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ClinicalTrials.gov Identifier: NCT04123158
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
Prof. Antonia Testa
Dr. Daniela Romualdi
Dr. Francesca Ciccarone
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Brief Summary:

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

Primary Aim:To assess the accuracy of a diagnostic algorithm in identifing patients with uterine sarcomas in women with at least one > =3 cm myometrial lesion.


Condition or disease Intervention/treatment
Sarcoma Uterus Diagnostic Test: Ultrasound Diagnostic Test: MRI

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MYometrial Lesion UltrasouNd And mRi
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : March 12, 2021
Estimated Study Completion Date : March 12, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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

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
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; ]

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 15 days and triaged to surgery (to be performed within 30 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
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]





Primary Outcome Measures :
  1. Myometrial Lesion [ Time Frame: March 2018 -March 2023 ]
    A myometrial lesion with the largest diameter >3 cm represents the target lesion. In case of multiple myometrial lesions with similar ultrasound morphology, the largest tumor will be selected as target lesion. In case of multiple myometrial lesions with different ultrasound morphology, the "target lesion" will be identified by the ultrasound examiner on the basis of the parameters subjectively considered suspicious for malignancy.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a myometrial lesion with the largest diameter >3 cm that represents the target lesion
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123158


Contacts
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Contact: Francesca Ciccarone, M.D. 00390630154979 fr.ciccarone@gmail.com

Locations
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Italy
Fondazione Policlinico Agostino Gemelli Recruiting
Rome, Italy, 00191
Contact: Francesca Ciccarone, M.D.    00390630154979    fr.ciccarone@gmail.com   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Prof. Antonia Testa
Dr. Daniela Romualdi
Dr. Francesca Ciccarone
Investigators
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Principal Investigator: Giovanni Scambia, Professor Fondazione Policlinico Agostino Gemelli

Publications of Results:
Other Publications:
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Responsible Party: Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT04123158     History of Changes
Other Study ID Numbers: M.Y.L.U.N.A.R. CICOG-2-3-18/60
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
Ultrasound
Myoma
MRI
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms