Endometrial CancerPhase 3SENGANCT05446324
Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer
A Phase 3 study testing Gallium-68-tilmanocept in people with Endometrial Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer. 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?
- Gallium-68-tilmanocept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2023to 1 Sep 2024
- Phase
- Phase 3
- 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
- Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer;
- Scheduled for robot-assisted full pelvic and para-aortic staging;
- Age ≥18 years and able to provide informed consent.
Who cannot join
- Pregnancy or current breastfeeding;
- Prior severe allergic reaction to iodine;
- Severe renal insufficiency (stage 3 or 4);
- Clinical or radiological evidence of metastatic disease.
Trial locations and contacts
1 site in 1 country.
Ilse G.T. Baeten, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Cornelis G Gerestein
Utrecht, 3584CX
Cornelis G Gerestein, MD, PhD, +31616770541, C.G.Gerestein-2@umcutrecht.nl
Cornelis G. Gerestein, MD,PhD
About this study
Official title: SENtinel Lymph Node Mapping With GAllium-68-tilmanocept PET/CT in High/High-intermediate Risk Endometrial Cancer: a Pilot Study
This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.
Read the detailed description
Rationale: Currently, the use of indocyanine green (ICG) is the most widely accepted sentinel lymph node (SLN) mapping technique in endometrial cancer but the acquired SLN detection rates greatly vary. We propose that adding preoperative imaging with the radiotracer Gallium-68-tilmanocept (68Ga-tilmanocept) PET/CT can further improve SLN mapping in patients with endometrial cancer and reliably guide the surgeon towards the true SLN intraoperatively.
Objective: To evaluate the feasibility of sentinel lymph node imaging with 68Ga-tilmanocept PET/CT.
Study design: Non-randomised, single-centre, single-arm pilot study in the UMC Utrecht.
Study population: Patients with clinically stage I-II high/high-intermediate risk endometrial cancer scheduled for robot-assisted pelvic and para-aortic lymphatic staging (including SLN procedure). A total of 10 patients will be included.
Intervention (if applicable): Preoperative cervical injection of 68Ga-tilmanocept followed by preoperative PET/CT imaging (in adjunct to the standard-of-care: intraoperative injection with indocyanine green (ICG) with real-time near-infrared (NIR) fluorescence imaging). Injection of 68Ga-tilmanocept is performed by the gynaecologist in an outpatient setting. The PET/CT (PET + contrast enhanced CT abdomen) will be performed 30-90 minutes after tracer injection.
Main study parameters/endpoints: Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping, which is evaluated by its SLN detection rate.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Extra burden for subjects concerns an additional site visit for cervical injection followed by PET/CT imaging with a total duration of two hours (including waiting time of ~60 minutes). The preoperative injection with 68Ga-tilmanocept while patient is awake adds minimal discomfort to the patient. The extra administration of 10 MBq 68Ga-tilmanocept followed by PET/CT, resulting in a radiation of 6.3 mSv, is considered an acceptable radiation burden to the subjects. Adverse reactions after injection of radiolabelled tilmanocept rarely occur. No additional blood samples, follow-up visits or physical examinations are needed during this study. The additional site visit does not delay the scheduled standard care.
Subjects may benefit from this study since the SLN detection rate could be increased and/or faster by adding 68Ga-tilmanocept PET/CT to the diagnostic procedure.
- Conditions
- Endometrial Cancer
- Being tested
- Gallium-68-tilmanocept
- Keywords
- Endometrial cancer, Sentinel lymph node mapping, Image guided surgery
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-68-tilmanoceptDrug
Also called 68Ga-tilmanocept
All participants receive a cervical injection with 10 MBq 68Ga-tilmanocept in an outpatient setting (at least one week) before surgery. Within 30-90 minutes post-injection a PET with contrast enhanced CT is performed (PET/CT). Data (i.e. detection rate) from the imaging modalities are collected.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-tilmanocept PET/CT | Experimental | All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG). Receives: Drug: Gallium-68-tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping
Assessed by the SLN detection rate with 68Ga-tilmanocept PET/CT. Overall SLN detection rate is defined as the proportion of patients in which at least one SLN is detected. Bilateral SLN detection rate is defined as the proportion of patients with at least one SLN detected in each hemipelvis or para-aortic side.
Measured: One week post-PET/CT
Secondary outcomes (3)
Correlation between SLN detection rate and anatomical location with preoperative 68Ga-tilmanocept PET/CT versus intraoperative ICG with near-infrared fluorescence.
Preoperative and intraoperative localisation of the detected SLNs will be reported according to a fixed format.
Measured: Intraoperative
Pathological status of SLNs
Assessed as: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameter between 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells).
Measured: One week post-surgery
Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT
Graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0)
Measured: Up to one hour post-PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Feb 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Zweemer, UMC Utrecht
- Investigators
- Cornelis G Gerestein, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446324
- Sponsor's protocol ID
- NL81058.041.22
- Acronym
- SENGA
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENtinel Lymph Node Mapping With GAllium-68-tilmanocept PET/CT in High/High-intermediate Risk Endometrial Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT05446324
- Acronym / sponsor ID
- SENGA / NL81058.041.22
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Sentinel lymph node mapping, Image guided surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- 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.
This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.
Detailed description
Rationale: Currently, the use of indocyanine green (ICG) is the most widely accepted sentinel lymph node (SLN) mapping technique in endometrial cancer but the acquired SLN detection rates greatly vary. We propose that adding preoperative imaging with the radiotracer Gallium-68-tilmanocept (68Ga-tilmanocept) PET/CT can further improve SLN mapping in patients with endometrial cancer and reliably guide the surgeon towards the true SLN intraoperatively.
Objective: To evaluate the feasibility of sentinel lymph node imaging with 68Ga-tilmanocept PET/CT.
Study design: Non-randomised, single-centre, single-arm pilot study in the UMC Utrecht.
Study population: Patients with clinically stage I-II high/high-intermediate risk endometrial cancer scheduled for robot-assisted pelvic and para-aortic lymphatic staging (including SLN procedure). A total of 10 patients will be included.
Intervention (if applicable): Preoperative cervical injection of 68Ga-tilmanocept followed by preoperative PET/CT imaging (in adjunct to the standard-of-care: intraoperative injection with indocyanine green (ICG) with real-time near-infrared (NIR) fluorescence imaging). Injection of 68Ga-tilmanocept is performed by the gynaecologist in an outpatient setting. The PET/CT (PET + contrast enhanced CT abdomen) will be performed 30-90 minutes after tracer injection.
Main study parameters/endpoints: Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping, which is evaluated by its SLN detection rate.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Extra burden for subjects concerns an additional site visit for cervical injection followed by PET/CT imaging with a total duration of two hours (including waiting time of ~60 minutes). The preoperative injection with 68Ga-tilmanocept while patient is awake adds minimal discomfort to the patient. The extra administration of 10 MBq 68Ga-tilmanocept followed by PET/CT, resulting in a radiation of 6.3 mSv, is considered an acceptable radiation burden to the subjects. Adverse reactions after injection of radiolabelled tilmanocept rarely occur. No additional blood samples, follow-up visits or physical examinations are needed during this study. The additional site visit does not delay the scheduled standard care.
Subjects may benefit from this study since the SLN detection rate could be increased and/or faster by adding 68Ga-tilmanocept PET/CT to the diagnostic procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-tilmanocept PET/CT | Experimental | Drug: Gallium-68-tilmanoceptAll participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer;
- Scheduled for robot-assisted full pelvic and para-aortic staging;
- Age ≥18 years and able to provide informed consent.
Key exclusion criteria (4 listed)
- Pregnancy or current breastfeeding;
- Prior severe allergic reaction to iodine;
- Severe renal insufficiency (stage 3 or 4);
- Clinical or radiological evidence of metastatic disease.
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 |
|---|---|---|
| Gallium-68-tilmanoceptAlso: 68Ga-tilmanoceptAll participants receive a cervical injection with 10 MBq 68Ga-tilmanocept in an outpatient setting (at least one week) before surgery. Within 30-90 minutes post-injection a PET with contrast enhanced CT is performed (PET/CT). Data (i.e. detection rate) from the imaging modalities are collected. | Drug | 68Ga-tilmanocept PET/CT |
Primary outcome
Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping
Time frame: One week post-PET/CT
Assessed by the SLN detection rate with 68Ga-tilmanocept PET/CT. Overall SLN detection rate is defined as the proportion of patients in which at least one SLN is detected. Bilateral SLN detection rate is defined as the proportion of patients with at least one SLN detected in each hemipelvis or para-aortic side.
3 secondary outcomes
Correlation between SLN detection rate and anatomical location with preoperative 68Ga-tilmanocept PET/CT versus intraoperative ICG with near-infrared fluorescence.
Time frame: Intraoperative
Pathological status of SLNs
Time frame: One week post-surgery
Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT
Time frame: Up to one hour post-PET/CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- 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.
Ilse G.T. Baeten, MD contact
Cornelis G Gerestein, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gallium-68-tilmanocept in people with Endometrial Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 4 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 1 Dec 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cornelis G Gerestein, MD, PhD (+31616770541, C.G.Gerestein-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping (time frame: One week post-PET/CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.