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Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW

NCT06095362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

  • Thyroid Carcinoma
  • Surgery

Interventions

DRUG

Bevacizumab-IRDye800CW

All patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2023-10-12
Completion
2023-10-12

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095362 on ClinicalTrials.gov