Endometrial CancerPhase 2NCT04511026
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
A Phase 2 study testing Lymphoseek, Single Photon Emission Computed Tomography (SPECT) and Indocyanine Green (ICG) in people with Endometrial Cancer, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Lymphoseek, Single Photon Emission Computed Tomography (SPECT) and Indocyanine Green (ICG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 10 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has histological diagnosis of cancer of the endometrium of any histology or grade.
- The patient should have received no prior treatment for her endometrial cancer.
- The patient has clinically uterine confined disease.
- The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care.
- The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.
- If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
- The patient has provided written informed consent.
- The patient is at least 18 years of age at the time of consent
Who cannot join
- The patient has clinical or radiological evidence of metastatic disease.
- The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix.
- The patient has participated in another investigational drug study within 30 days of scheduled surgery.
- The patient has an iodine allergy.
- The patient is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94304
About this study
Official title: Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
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.
Read the detailed description
Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green.
Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.
- Conditions
- Endometrial Cancer
- Being tested
- Lymphoseek, Single Photon Emission Computed Tomography (SPECT), Indocyanine Green (ICG), Neoprobe Gamma Detection System NPB11L(Model1102)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoseekDrug
Also called technetium Tc 99m tilmanocept
Radioactive diagnostic agent
Single Photon Emission Computed Tomography (SPECT)Device
Imaging test
Indocyanine Green (ICG)Drug
Cyanine dye used in medical diagnostics manufactured by Akorn Inc.
Neoprobe Gamma Detection System NPB11L(Model1102)Device
Also called Laparoscopic handheld gamma counter
Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoseek/SPECT-CT/Indocyanine | Experimental | The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery. Receives: Drug: Lymphoseek; Device: Single Photon Emission Computed Tomography (SPECT); Drug: Indocyanine Green (ICG); Device: Neoprobe Gamma Detection System NPB11L(Model1102) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Bilateral SLNs
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.
Measured: during surgery, an average of 3 hours
Secondary outcomes (5)
Overall Detection of SLN Detection
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'.
Measured: during surgery, an average of 3 hours
Number of SLNs Detected by Lymphoseek:
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.
Measured: during surgery, an average of 3 hours
Location of SLNs Detected by Lymphoseek:
The location and 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.
Measured: during surgery, an average of 3 hours
Number of SLNs Detected by Indocyanine Green
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.
Measured: during surgery, an average of 3 hours
Location of SLNs Detected by Indocyanine Green
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.
Measured: during surgery, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start20 Jan 2021
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Why it stopped: Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Karam, Stanford University
- Investigators
- Amer K Karam, MD, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511026
- Sponsor's protocol ID
- IRB-53978
- Other IDs
- GYNEND0006, IRB-53978
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2020
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy RA, Moon AS, Chow S, Heilbroner L, Howitt B, Diver E, Dorigo O, Litkouhi B, Renz M, Karam A. Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer. Gynecol Oncol Rep. 2022 Jul 30;43:101054. doi: 10.1016/j.gore.2022.101054. eCollection 2022 Oct.
PubMed 35958955
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
- ClinicalTrials.gov ID
- NCT04511026
- Acronym / sponsor ID
- IRB-53978
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green.
Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoseek/SPECT-CT/Indocyanine | Experimental | Drug: Lymphoseek, Device: Single Photon Emission Computed Tomography (SPECT), Drug: Indocyanine Green (ICG), Device: Neoprobe Gamma Detection System NPB11L(Model1102)The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient has histological diagnosis of cancer of the endometrium of any histology or grade.
- The patient should have received no prior treatment for her endometrial cancer.
- The patient has clinically uterine confined disease.
- The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care.
- The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.
Key exclusion criteria (5 listed)
- The patient has clinical or radiological evidence of metastatic disease.
- The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix.
- The patient has participated in another investigational drug study within 30 days of scheduled surgery.
- The patient has an iodine allergy.
- The patient is pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LymphoseekAlso: technetium Tc 99m tilmanoceptRadioactive diagnostic agent | Drug | Lymphoseek/SPECT-CT/Indocyanine |
| Single Photon Emission Computed Tomography (SPECT)Imaging test | Device | Lymphoseek/SPECT-CT/Indocyanine |
| Indocyanine Green (ICG)Cyanine dye used in medical diagnostics manufactured by Akorn Inc. | Drug | Lymphoseek/SPECT-CT/Indocyanine |
| Neoprobe Gamma Detection System NPB11L(Model1102)Also: Laparoscopic handheld gamma counterNeoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc. | Device | Lymphoseek/SPECT-CT/Indocyanine |
Primary outcome
Number of Participants With Bilateral SLNs
Time frame: 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.
5 secondary outcomes
Overall Detection of SLN Detection
Time frame: during surgery, an average of 3 hours
Number of SLNs Detected by Lymphoseek:
Time frame: during surgery, an average of 3 hours
Location of SLNs Detected by Lymphoseek:
Time frame: during surgery, an average of 3 hours
Number of SLNs Detected by Indocyanine Green
Time frame: during surgery, an average of 3 hours
Location of SLNs Detected by Indocyanine Green
Time frame: during surgery, an average of 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35958955Reddy RA, Moon AS, Chow S, Heilbroner L, Howitt B, Diver E, Dorigo O, Litkouhi B, Renz M, Karam A. Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer. Gynecol Oncol Rep. 2022 Jul 30;43:101054. doi: 10.1016/j.gore.2022.101054. eCollection 2022 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amer K Karam, MD principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lymphoseek, Single Photon Emission Computed Tomography (SPECT) and Indocyanine Green (ICG) in people with Endometrial Cancer, run by Stanford University at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Bilateral SLNs (time frame: during surgery, an average of 3 hours). 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 NCT04511026, which also lists 1 linked publication.
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 11 Oct 2023.