Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer
NCT ID: NCT05446324
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
10 participants
INTERVENTIONAL
2023-02-15
2024-09-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-tilmanocept PET/CT
All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG).
Gallium-68-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.
Interventions
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Gallium-68-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for robot-assisted full pelvic and para-aortic staging;
* Age ≥18 years and able to provide informed consent.
Exclusion Criteria
* Prior severe allergic reaction to iodine;
* Severe renal insufficiency (stage 3 or 4);
* Clinical or radiological evidence of metastatic disease.
18 Years
FEMALE
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Ronald Zweemer
Prof. dr. Ronald P. Zweemer
Principal Investigators
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Cornelis G Gerestein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Cornelis G Gerestein
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Cornelis G Gerestein, MD, PhD
Role: primary
Other Identifiers
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NL81058.041.22
Identifier Type: -
Identifier Source: org_study_id