Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Phase 2 Terminated 6 enrolled Stanford University

NaSingle-groupOpen-labelDiagnostic

Summary

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Timeline

Start: 2021-01-20
Primary completion: 2021-06-10
Completion: 2021-06-10

Outcome

Missed primary endpoint

Stopped: “Efficacy”

paper Tilmanocept did not map any SLN in the first six patients but instead showed retention of the tracer in the cervical stroma, leading to study discontinuation for futility. PMID 35958955 ↗

Publications

Results Reddy RA, Moon AS, Chow S, Heilbroner L, Howitt B, Diver E, Dorigo O, Litkouhi B, Renz M, Karam A. Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer. Gynecol Oncol Rep. 2022 Jul 30;43:101054. doi: 10.1016/j.gore.2022.101054. eCollection 2022 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Indocyanine Green	Diagnostic / imaging agent	0.5 ml	Other
Subject	Technetium Tc 99m Tilmanocept	Diagnostic / imaging agent	0.5 ml	Other