Uterine Cervical NeoplasmsSENTIREC IINCT02820506
Sentinel Node Mapping in Women With Endometrial and Cervical Cancer
A study testing SLN mapping and removal of PET-positive lymph nodes in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Southern Denmark at 4 sites in Denmark.
Trial summary
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Uterine Neoplasms
- What is being tested?
- SLN mapping and removal of PET-positive lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesDenmark
- Study dates
- 27 Feb 2017to 31 Jan 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
- Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.
Who cannot join
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Being tested
- SLN mapping and removal of PET-positive lymph nodes
- Keywords
- robotic surgery procedures, indocyanine green, sentinel lymph node mapping
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN mapping and removal of PET-positive lymph nodesProcedure or surgery
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| High risk endometrial cancer | Other | Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy. Receives: Procedure: SLN mapping and removal of PET-positive lymph nodes |
| Cervical cancer tumor size 2-4 cm | Other | Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy. Receives: Procedure: SLN mapping and removal of PET-positive lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Measured: 2 years
Negative predictive value
Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes
Measured: 2 years
Secondary outcomes (6)
Specificity
Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Measured: 2 years
Positive predictive value
Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Measured: 2 years
Prevalence of lymph node metastasis
Prevalence of lymph node metastasis in the pelvis and paraaortic area
Measured: 2 years
Incidence of lymphedema
Using patient reported outcome measures
Measured: 3 years
Severity of lymphedema
Using patient reported outcome measures
Measured: 3 years
Quality of life rate
Using patient reported outcome measures
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start27 Feb 2017
- Primary completion31 Jan 2023
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed. Cervical cancer: Study is diagnostic and primarily explorative.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Danish Cancer Society
- Responsible party
- Principal investigator, Sara Sponholtz, University of Southern Denmark
- Investigators
- Pernille T Jensen, Professor, Principal investigator, Aarhus University Hospital and Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820506
- Sponsor's protocol ID
- SDUSF12015163 1 (198)1
- Acronym
- SENTIREC II
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2016
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
PubMed 33829991
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02820506
- Acronym / sponsor ID
- SENTIREC II / SDUSF12015163 1 (198)1
- Conditions
- Uterine Cervical Neoplasms, Uterine Neoplasms
- Keywords
- robotic surgery procedures, indocyanine green, sentinel lymph node mapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Danish Cancer Society
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed. Cervical cancer: Study is diagnostic and primarily explorative.
| Arm | Type | Receives |
|---|---|---|
| High risk endometrial cancer | Other | Procedure: SLN mapping and removal of PET-positive lymph nodesPatients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy. |
| Cervical cancer tumor size 2-4 cm | Other | Procedure: SLN mapping and removal of PET-positive lymph nodesPatients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
- Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.
Key exclusion criteria (3 listed)
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
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 |
|---|---|---|
| SLN mapping and removal of PET-positive lymph nodesSentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes | Procedure or surgery | Cervical cancer tumor size 2-4 cm, High risk endometrial cancer |
Primary outcome
Sensitivity
Time frame: 2 years
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Negative predictive value
Time frame: 2 years
Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes
6 secondary outcomes
Specificity
Time frame: 2 years
Positive predictive value
Time frame: 2 years
Prevalence of lymph node metastasis
Time frame: 2 years
Incidence of lymphedema
Time frame: 3 years
Severity of lymphedema
Time frame: 3 years
Quality of life rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 33829991Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
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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.
Pernille T Jensen, Professor principal investigator
Aarhus University Hospital and Aarhus University, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLN mapping and removal of PET-positive lymph nodes in people with Uterine Cervical Neoplasms and Uterine Neoplasms, run by University of Southern Denmark at 4 sites in Denmark.
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 2 inclusion and 3 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 8 Feb 2024. 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 Denmark. 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?
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?
Sensitivity (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02820506, 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 8 Feb 2024.