Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW (TARGET-beva)

October 18, 2023 updated by: University Medical Center Groningen

Thyroid Cancer and Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW With Molecular Fluorescence Guided Surgery. Thyroid cAncer Surgery With Intraoperative Molecular fluoRescent Imaging to rEduce overtreatmenT and Morbidity

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Age ≥ 18 years, eligible for surgery
  2. Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence).
  3. Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.
  4. WHO performance score of 0-2.
  5. Written informed consent.
  6. Mentally competent person who is able and willing to comply with study procedures.

  7. For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal:

    • A negative serum pregnancy test prior to receiving the tracer
    • Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion criteria

  1. Pregnancy or breast feeding
  2. Advanced stage thyroid cancer not suitable for surgical resection
  3. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
  5. The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months
  6. History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment
  7. Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Drug: Bevacizumab-IRDye800CW
All patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC/FTC/HTC nodal metastasis and normal tissue to determine the optimal dose of Bevacizumab-800CW in patients with PTC/FTC/HTC
Time Frame: Whole study
Whole study

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of the fluorescent signal assessed by MFGS with other biological and molecular parameters (IHC) and the fluorescent signal assessed in the ex vivo biopsy specimens.
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Wound bed biopsy specimen characteristics (number of positive and negative biopsies.
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Distribution of bevacizumab-IRDye800CW in PTC/FTC/HTC, lymph nodes and normal tissue as identified by SDS-PAGE and/or ELISA and/or fluorescence microscopy.
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Quantification of sensitivity and specificity of Bevacizumab-800CW in order to make a power size calculation for a possible subsequent diagnostic accuracy study.
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Dutch Cancer Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202000846

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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