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

Primary Purpose

Thyroid Carcinoma, Surgery

Status
Enrolling by invitation
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Bevacizumab-IRDye800CW
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Carcinoma focused on measuring Optical Molecular Imaging, Molecular Fluorescence Guided Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Age ≥ 18 years, eligible for surgery Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence). Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board. WHO performance score of 0-2. Written informed consent. Mentally competent person who is able and willing to comply with study procedures. 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 Pregnancy or breast feeding Advanced stage thyroid cancer not suitable for surgical resection Medical or psychiatric conditions that compromise the patient's ability to give informed consent Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months 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 Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Wound bed biopsy specimen characteristics (number of positive and negative biopsies.
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.
Quantification of sensitivity and specificity of Bevacizumab-800CW in order to make a power size calculation for a possible subsequent diagnostic accuracy study.

Full Information

First Posted
October 10, 2023
Last Updated
October 18, 2023
Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT06095362
Brief Title
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
Acronym
TARGET-beva
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Surgery
Keywords
Optical Molecular Imaging, Molecular Fluorescence Guided Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab-IRDye800CW
Intervention Description
All patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Wound bed biopsy specimen characteristics (number of positive and negative biopsies.
Time Frame
through study completion, an average of 2 years
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Age ≥ 18 years, eligible for surgery Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence). Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board. WHO performance score of 0-2. Written informed consent. Mentally competent person who is able and willing to comply with study procedures. 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 Pregnancy or breast feeding Advanced stage thyroid cancer not suitable for surgical resection Medical or psychiatric conditions that compromise the patient's ability to give informed consent Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months 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 Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.omig.nl
Description
Optical Molecular Imaging Group Groningen

Learn more about this trial

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

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