Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
Status:
Enrolling by invitation
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
Background: Papillary thyroid cancer (PTC) patients often develop central lymph node
metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central
lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent
local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk.
Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND.
Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent
tracers to detect cancerous tissue. This study aims to investigate whether the administration
of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can
enable intraoperative selection of PTC/FTC/HTC patients for CLND.
Objective: The primary objective of the study is to determine the optimal dose of
bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph
node metastases. The secondary objectives are to evaluate the feasibility of MFGS for
PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals
detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the
distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the
sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis.
Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective,
single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which
the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will
initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with
lymph node metastasis in each group. Dosages will be based on previous studies, with the
primary objective being the detection of lymph node metastasis. After the first 9 patients,
an interim analysis will be performed, after which the best dosage group will be expanded
with another 7 patients.
Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in
selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs
while maintaining effectiveness with a lower recurrence rate and improved quality of life.