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

NCT05446324 | Unknown Phase 3

• 1 other identifier: NL81058.041.22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Sentinel lymph node mapping; Image guided surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between SLN detection rate and anatomical location with preoperative 68Ga-tilmanocept PET/CT versus intraoperative ICG with near-infrared fluorescence.

  Intraoperative

• Pathological status of SLNs

  One week post-surgery

• Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT

  Up to one hour post-PET/CT

Study Arms (1)

68Ga-tilmanocept PET/CT

EXPERIMENTAL

All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG).

Drug: Gallium-68-tilmanocept

Interventions

Gallium-68-tilmanocept DRUG

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.

Also known as: 68Ga-tilmanocept

68Ga-tilmanocept PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

Cornelis G Gerestein

Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

gallium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cornelis G Gerestein, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cornelis G Gerestein, MD, PhD

CONTACT

+31616770541; C.G.Gerestein-2@umcutrecht.nl

Ilse G.T. Baeten, MD

CONTACT

i.g.t.baeten@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Ronald P. Zweemer

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: February 15, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)