AzTrials
AzTrials

Prostate CancerLPM-012NCT04632251

Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

A study testing SENSEI® in people with Prostate Cancer, run by Lightpoint Medical Limited at 4 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
SENSEI®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesin 4 countries
Study dates
16 Sep 2020to Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Subjects who have received prior prostate cancer treatment or prior pelvic surgery;
  • 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.

Trial locations and contacts

4 sites in 4 countries.

Lluis Fumado Ciutat contact

+34 650 947 553

LFumado@parcdesalutmar.cat

4 sites in 4 countries

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven, 3000

    Wouter Evearaets, +3216346930, wouter.everaerts@uzleuven.be

    Wouter Evearaets

    Not yet recruiting

Other trials in Belgium

France1 site, 1 recruiting

  • Institute Paoli-Calmettes

    Marseille, 13009

    Jochen Walz, +33 491 223532, WALZJ@ipc.unicancer.fr

    Jochen Walz

    Not yet recruiting

Other trials in France

Germany1 site, 1 recruiting

  • University Hospital Essen

    Essen, 45147

    Boris Hadaschik, +492017233210, Boris.HadaschikC@.uk-essen.de

    Boris Hadaschik

    Not yet recruiting

Other trials in Germany

Spain1 site, 1 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Lluis Fumado Ciutat, +34 650 947 553, LFumado@parcdesalutmar.cat

    Lluis Fumado Ciutat

    Recruiting

Other trials in Spain

About this study

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.

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

Conditions
Prostate Cancer
Being tested
SENSEI®
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SENSEI®Device

    SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system

Study groups in NCT04632251
Study groupRoleWhat they receive
FamiliarisationOtherThe 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.
Receives: Device: SENSEI®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Length of study finish - 6 Months

Secondary outcomes (14)

  1. 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.

    Measured: Length of study finish - 6 Months

  2. Diagnostic performance of the SENSEI® laparoscopic tethered gamma probe for detecting SLNs

    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.

    Measured: Length of study finish - 6 Months

  3. Overall ease of use of the SENSEI® laparoscopic tethered gamma probe.

    Measured: Length of study finish - 6 Months

  4. Radiation safety measurements for the staff.

    Measured: Length of study finish - 6 Months

  5. Duration of surgery

    Outcome will be measured from the first skin incision to skin closure (skin to skin).

    Measured: Length of study finish - 6 Months

  6. In centres using a conventional rigid laparoscopic gamma probe:

    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.

    In centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe

    Measured: Length of study finish - 6 Months

  7. Comparison of detection rates between robotic, open and manual laparoscopic surgery

    Measured: Length of study finish - 6 Months

  8. Incidence of study-related Adverse Events

    Measured: Length of study finish - 6 Months

  9. Complication rate as measured by Clavien-Dindo classification

    Measured: Length of study finish - 6 Months

  10. In centres using a conventional rigid laparoscopic gamma probe: Overall ease of use of the conventional rigid laparoscopic gamma probe

    Outcome will be assessed using questionnaire and ethnographic observations, and at similar time points.

    Measured: Length of study finish - 6 Months

  11. Duration of Sentinel Lymph Node Biopsy separately for each probe used

    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.

    Measured: Length of study finish - 6 Months

  12. Sentinel Lymph Node detection Rate

    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

    Measured: Length of study finish - 6 Months

  13. Number of Sentinel Lymph Nodes

    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.

    Measured: Length of study finish - 6 Months

  14. 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.

    Measured: Length of study finish - 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start16 Sep 2020
  3. Primary completion16 Feb 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632251
Sponsor's protocol ID
LPM-012
Acronym
LPM-012
Status last verified
Nov 2020
First submitted
21 Sep 2020
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Everaerts W, Walz J, Abascal Junquera JM, Goffin K, Grootendorst MR, van 't Klooster K, Juanpere N, Valhondo-Rama R, Vidal-Sicart S, Fumado L. A Multicentre Clinical Trial Evaluating a Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer. Eur Urol Focus. 2024 Jan;10(1):32-40. doi: 10.1016/j.euf.2023.07.001. Epub 2023 Jul 24.

    PubMed 37495459

  • 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.

    PubMed 36723880

Questions about this trial

What is this clinical trial studying?

A study testing SENSEI® in people with Prostate Cancer, run by Lightpoint Medical Limited at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lluis Fumado Ciutat (+34 650 947 553, LFumado@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Length of study finish - 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04632251, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in