Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04882618
Status:
UNKNOWN
Last Update Posted:
2021-05-12
First Post:
2021-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective single arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-08', 'studyFirstSubmitDate': '2021-01-31', 'studyFirstSubmitQcDate': '2021-05-08', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indocyanine green postive lymph node numbers', 'timeFrame': '15 day after surgery', 'description': 'total number of dissected lymph nodes which are indocyanine green positive'}, {'measure': 'Total lymph node numbers of conventional extended lymph node dissection', 'timeFrame': '15 day after surgery', 'description': 'total number of dissected lymph nodes during conventional extended lymph node dissection'}, {'measure': 'pathology of indocyanine green positive lymph nodes', 'timeFrame': '15 day after surgery', 'description': 'İndocyanine green positvie lymph nodes are malign or benign'}, {'measure': 'pathology of lymph nodes', 'timeFrame': '15 day after surgery', 'description': 'Pathology of material from conventional extended lymph node dissection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indocyanine green based fluorescence imaging', 'extendend lymph node dissection', 'prostate cancer'], 'conditions': ['Prostate Cancer', 'Lymph Node Metastases']}, 'descriptionModule': {'briefSummary': 'Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost.\n\nIt is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?', 'detailedDescription': '50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study.\n\nBefore Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy.\n\nExtended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately.\n\nPositive LN yield pf ICG guided LND and conventional LND is compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed locally limited prostate cancer;\n* Intermediate or high risk tumor\n* Recommended and planned prostatectomy;\n* Completed and signed written consent;\n* Voluntarily agreement to participate in this study\n* Age of the study participants ≥ 18 years.\n\nExclusion Criteria:\n\n* Allergic reaction to active ingredient (indocyanine green);\n* Iodine allergy;\n* Hyperthyroidism;\n* High-grade renal impairment;\n* High-grade hepatic insufficiency;\n* Unwillingness to the storage and disclosure of pseudonymous disease and personal data\n* psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question'}, 'identificationModule': {'nctId': 'NCT04882618', 'briefTitle': 'Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?', 'orgStudyIdInfo': {'id': 'TSA-2019-9393'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICG group', 'description': 'ICG injection before LRRP via cystoscopy', 'interventionNames': ['Drug: Indocyanine green']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'DRUG', 'otherNames': ['Conventional ELND'], 'description': 'indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy', 'armGroupLabels': ['ICG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Abdullah Demirtas, MD', 'role': 'CONTACT', 'email': 'mesane@gmail.com', 'phone': '+905325094494'}], 'facility': 'Department of Urology, Ercieys University, Faculty Of Medicine,', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Abdullah A Demirtaş, MD, PRof', 'role': 'CONTACT', 'email': 'mesane@gmail.com', 'phone': '+905325094494'}, {'name': 'Şevket TOLGA T Tombul, MD', 'role': 'CONTACT', 'email': 'sevkettolgatombul@hotmail.com', 'phone': '05364774525'}], 'overallOfficials': [{'name': 'Abdullah A Demirtaş, Md, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor in Urology', 'investigatorFullName': 'Abdullah Demirtas', 'investigatorAffiliation': 'TC Erciyes University'}}}}