Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT04632251
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-17', 'releaseDate': '2022-12-15'}], 'estimatedResultsFirstSubmitDate': '2022-12-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sentinel lymph node (SLN) detection rate with the SENSEI® laparoscopic tethered gamma probe. Detection rate is defined as the percentage of patients with at least one SLN detected intraoperatively.', 'timeFrame': 'Length of study finish - 6 Months'}], 'secondaryOutcomes': [{'measure': 'Number of SLNs detected with the SENSEI® laparoscopic tethered gamma probe in comparison to preoperative planar LS and SPECT/CT in centres with a SPECT/CT scanner.', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'Diagnostic performance of the SENSEI® laparoscopic tethered gamma probe for detecting SLNs', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'Diagnostic performance include sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV). Histopathological tumour status of lymph nodes excised based on the ePLND template will be used as reference standard.'}, {'measure': 'Overall ease of use of the SENSEI® laparoscopic tethered gamma probe.', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'Radiation safety measurements for the staff.', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'Duration of surgery', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'Outcome will be measured from the first skin incision to skin closure (skin to skin).'}, {'measure': 'In centres using a conventional rigid laparoscopic gamma probe:', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'SLN detection rate, number of SLNs, diagnostic performance and in vivo and ex vivo count rate of the SENSEI® laparoscopic tethered gamma probe in comparison to the conventional rigid laparoscopic gamma probe.\n\nIn centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe'}, {'measure': 'Comparison of detection rates between robotic, open and manual laparoscopic surgery', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'Incidence of study-related Adverse Events', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'Complication rate as measured by Clavien-Dindo classification', 'timeFrame': 'Length of study finish - 6 Months'}, {'measure': 'In centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'Outcome will be assessed using questionnaire and ethnographic observations, and at similar time points.'}, {'measure': 'Duration of Sentinel Lymph Node Biopsy separately for each probe used', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'Duration of SLNB will be measured from the first in vivo measurement to completion of ex vivo measurements of excised SLN specimens and measured separately for each probe used. The end time of ex vivo measurements of the excised ePLND specimens will also be recorded.'}, {'measure': 'Sentinel Lymph Node detection Rate', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'The 95% Confidence Interval (CI) around the detection rate will allow an estimate of the true detection rate. The sample size directly impacts the precision of the estimate. The sample size of 40 evaluable patients has been selected to provide a reasonable level of precision for the estimate of the SLN detection rate'}, {'measure': 'Number of Sentinel Lymph Nodes', 'timeFrame': 'Length of study finish - 6 Months', 'description': 'Number of SLNs detected with the SENSEI® laparoscopic tethered gamma probe in comparison to preoperative planar LS and SPECT/CT in centres with a SPECT/CT scanner.'}, {'measure': 'Diagnostic performance and in vivo and ex vivo count rate of the SENSEI® laparoscopic tethered gamma probe in comparison to the conventional rigid laparoscopic gamma probe.', 'timeFrame': 'Length of study finish - 6 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36723880', 'type': 'DERIVED', 'citation': 'Abascal Junquera JM, Harke NN, Walz JC, Hadaschik B, Adshead J, Everaerts W, Goffin K, Grootendorst MR, Oldfield F, Vyas K, Fusco AM, Juanpere N, Vidal-Sicart S, Fumado L. A Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer: Preclinical Evaluation and Interim Results From a Multicenter Clinical Trial. Clin Nucl Med. 2023 Mar 1;48(3):213-220. doi: 10.1097/RLU.0000000000004557. Epub 2023 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.\n\nPatients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects who are ≥ 18 years of age with histologically proven prostate cancer; and who have signed an informed consent form prior to any study related activity • Subjects who are scheduled for radical prostatectomy with ePLND.\n\nExclusion Criteria:\n\n* Subjects who have received prior prostate cancer treatment or prior pelvic surgery;\n\n * Subjects who have an existing medical condition that would compromise their participation in the study;\n * Subjects with a history of hypersensitivity to 99mTc-nanocolloid or any excipients;\n * Subjects who are unable to give voluntary, written informed consent to participate in this study;\n * Subjects who are unable to understand this study and are not willing to complete all the study assessments.'}, 'identificationModule': {'nctId': 'NCT04632251', 'acronym': 'LPM-012', 'briefTitle': 'Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lightpoint Medical Limited'}, 'officialTitle': 'Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer', 'orgStudyIdInfo': {'id': 'LPM-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Familiarisation', 'description': 'The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study.', 'interventionNames': ['Device: SENSEI®']}], 'interventions': [{'name': 'SENSEI®', 'type': 'DEVICE', 'description': 'SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system', 'armGroupLabels': ['Familiarisation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wouter Evearaets', 'role': 'CONTACT', 'email': 'wouter.everaerts@uzleuven.be', 'phone': '+3216346930'}, {'name': 'Wouter Evearaets', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '13009', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jochen Walz', 'role': 'CONTACT', 'email': 'WALZJ@ipc.unicancer.fr', 'phone': '+33 491 223532'}, {'name': 'Jochen Walz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '45147', 'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Boris Hadaschik', 'role': 'CONTACT', 'email': 'Boris.HadaschikC@.uk-essen.de', 'phone': '+492017233210'}, {'name': 'Boris Hadaschik', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lluis Fumado Ciutat', 'role': 'CONTACT', 'email': 'LFumado@parcdesalutmar.cat', 'phone': '+34 650 947 553'}, {'name': 'Lluis Fumado Ciutat', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Lluis Fumado Ciutat', 'role': 'CONTACT', 'email': 'LFumado@parcdesalutmar.cat', 'phone': '+34 650 947 553'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lightpoint Medical Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-12-15', 'type': 'RELEASE'}, {'date': '2023-10-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lightpoint Medical Limited'}}}}