Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04554602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, specificity, positive predictive value (VPP) and negative predictive value (VPN) of fusion ultrasound compared to transvaginal ultrasound and MRI for the diagnosis of endometriosis lesions', 'timeFrame': '3 years and 3 months', 'description': 'To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.', 'timeFrame': '3 years and 3 months', 'description': 'Evaluation of the reproducibility by an intra-class correlation test for the conclusions of fusion ultrasound between two operators.'}, {'measure': 'To evaluate the contribution of fusion ultrasound in the follow-up of patients suffering from endometriosis, in particular with an ultrasound follow-up in comparison with an initial reference MRI in the case of medical or surgical management.', 'timeFrame': '3 years and 3 months', 'description': 'Correlation between the evolution of clinical and quality of life symptoms (EHP30 form and Short Form 36) and the evolution of lesion size between initial MRI and follow-up ultrasounds at 6 months and one year'}, {'measure': 'Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion', 'timeFrame': '3 years and 3 months', 'description': 'Comparison of the average examination time by a Student T-test between standard and fusion ultrasound.'}, {'measure': 'Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance', 'timeFrame': '3 years and 3 months', 'description': 'Comparison of imaging costs will be carried out over 3 years between a conventional procedure with annual MRI and the procedure being evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.', 'detailedDescription': 'The research is about diagnosis performance between fusion ultrasound and the gold standard (MRI coelioscopy ). Fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. During 39 months, 200 patients will be follow. In one arm, there is the control group with women without endometriosis. In the second arm, there is the patient with endometriosis. We will compare monitoring differences between gold standard and fusion ultrasound ( Cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any major patient with an indication for pelvic MRI and pelvic ultrasound outside a proven cancer indication (suspicion of endometriosis or other pathology for the control population).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 18 to 50 years old\n* Patient informed and who gave her non-opposition to participate in the research\n* Patient with an indication for pelvic MRI and pelvic ultrasound either for the exploration of endometriosis or pelvic pain, or for another gynaecological pathology (ovarian cyst, poly-myomatous uterus, uterine malformation) outside of a proven cancer indication.\n* Patient affiliated to a social security or entitled to a social security allowance\n\nExclusion Criteria:\n\n* Patient with a proven cancerous pathology at the time of the prescription of the complementary examinations.\n* Virgin patient\n* Pregnant patient\n* Patients under protective measures\n* Contraindication to MRI (claustrophobia, intracorporeal metallic foreign body)'}, 'identificationModule': {'nctId': 'NCT04554602', 'acronym': 'ENDOFUSION', 'briefTitle': 'Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION', 'orgStudyIdInfo': {'id': 'APHP191069'}, 'secondaryIdInfos': [{'id': '2019-A02828-49', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with endometriosis or suspicion of endometriosis', 'description': '* Information and collection of the non-objection before inclusion\n* Interrogation, clinical examination, EHP30 and SF36 form at inclusion\n* MRI, pelvic ultrasound (coupled with fusion ultrasound)\n* Laparoscopy if indicated after MRI, ultrasound and fusion ultrasound\n* Monitoring by form and fusion ultrasound at 6 months and then once a year for 3 years', 'interventionNames': ['Diagnostic Test: Fusion ultrasound']}, {'label': 'Patient with other gynaecological pathology', 'description': '* Information and collection of the non-opposition before inclusion\n* Interrogation, clinical examination, EHP30 and SF36 form at inclusion\n* MRI, pelvic ultrasound (coupled with fusion ultrasound)\n* laparoscopy if indicated after MRI, ultrasound and fusion ultrasound', 'interventionNames': ['Diagnostic Test: Fusion ultrasound']}], 'interventions': [{'name': 'Fusion ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.', 'armGroupLabels': ['Patient with endometriosis or suspicion of endometriosis', 'Patient with other gynaecological pathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'AP-HP, Bicêtre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Perrine CAPMAS, DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}