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NCT04511026

Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Terminated Phase 2 Results posted Last updated 11 October 2023
What this trial tests

Phase 2 trial testing Lymphoseek in Endometrial Cancer in 6 participants. Terminated before completion.

Timeline
20 January 2021
Primary endpoint
10 June 2021
10 June 2021

Quick facts

Lead sponsorStanford University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment6
Start date20 January 2021
Primary completion10 June 2021
Estimated completion10 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Bilateral SLNs Primary · during surgery, an average of 3 hours

A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device.

GroupValue95% CI
Lymphoseek/SPECT-CT/Indocyanine6
Overall Detection of SLN Detection Secondary · during surgery, an average of 3 hours

For each subject, an assessment will be made of whether there was overall sentinel node detection. A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device. If at least one SLN is detected (on any side), then this outcome will be considered a 'Yes'.

GroupValue95% CI
Lymphoseek/SPECT-CT/Indocyanine6
Number of SLNs Detected by Lymphoseek: Secondary · during surgery, an average of 3 hours

The number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device.

GroupValue95% CI
Lymphoseek/SPECT-CT/Indocyanine0
Number of SLNs Detected by Indocyanine Green Secondary · during surgery, an average of 3 hours

Number of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device.

GroupValue95% CI
Lymphoseek/SPECT-CT/Indocyanine28
Location of SLNs Detected by Indocyanine Green Secondary · during surgery, an average of 3 hours

Location of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device.

Common Iliac
GroupValue95% CI
Right-Sided SLN Locations2
Left-Sided SLN Locations1
External Iliac
GroupValue95% CI
Right-Sided SLN Locations8
Left-Sided SLN Locations9
Hypogastric
GroupValue95% CI
Right-Sided SLN Locations0
Left-Sided SLN Locations1
Obturator
GroupValue95% CI
Right-Sided SLN Locations1
Left-Sided SLN Locations6

Sponsor's own description

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer.
    Reddy RA, Moon AS, Chow S, Heilbroner L, et al · · 2022 · cited 3× · PMID 35958955 · DOI 10.1016/j.gore.2022.101054

Verify or expand the search:

Other trials of Lymphoseek

Trials testing the same drug.

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

Other Stanford University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04511026.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing