Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
NCT ID: NCT04632251
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2020-09-16
2021-08-31
Brief Summary
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Patients 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
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Familiarisation
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.
SENSEI®
SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system
Interventions
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SENSEI®
SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who have an existing medical condition that would compromise their participation in the study;
* Subjects with a history of hypersensitivity to 99mTc-nanocolloid or any excipients;
* Subjects who are unable to give voluntary, written informed consent to participate in this study;
* Subjects who are unable to understand this study and are not willing to complete all the study assessments.
18 Years
MALE
No
Sponsors
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Lightpoint Medical Limited
INDUSTRY
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Institute Paoli-Calmettes
Marseille, , France
University Hospital Essen
Essen, , Germany
Hospital del Mar
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Wouter Evearaets
Role: primary
Jochen Walz
Role: primary
Boris Hadaschik
Role: primary
Lluis Fumado Ciutat
Role: primary
References
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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.
Other Identifiers
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LPM-012
Identifier Type: -
Identifier Source: org_study_id