Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer (SENGA)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: Gallium-68-tilmanocept

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cornelis G Gerestein, MD, PhD; Phone Number: +31616770541; Email: C.G.Gerestein-2@umcutrecht.nl
• Study Contact Backup: Name: Ilse G.T. Baeten, MD; Email: i.g.t.baeten@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584CX
    • Recruiting
    • Cornelis G Gerestein
    • Principal Investigator: Cornelis G. Gerestein, MD,PhD
    • Sub-Investigator: Ilse G.T. Baeten, MD
    • Contact: Cornelis G Gerestein, MD, PhD; Phone Number: +31616770541; Email: C.G.Gerestein-2@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnancy or current breastfeeding;
• Prior severe allergic reaction to iodine;
• Severe renal insufficiency (stage 3 or 4);
• Clinical or radiological evidence of metastatic disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-tilmanocept PET/CT; All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG).	Drug: 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 Names: 68Ga-tilmanocept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One week post-PET/CT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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)	Up to one hour post-PET/CT

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Cornelis G Gerestein, MD, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Endometrial cancer; Image guided surgery; Sentinel lymph node mapping
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: NL81058.041.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No