Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095362
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-10-10
Brief Title:
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGET-beva
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 PTCFTCHTC 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 PTCFTCHTC lymph node metastases The secondary objectives are to evaluate the feasibility of MFGS for PTCFTCHTC 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 PTCFTCHTC 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 PTCFTCHTC for which the best TBR dosage group in PTCFTCHTC nodal metastasis will be determined The study will initiate with a 3 x 3 scheme 45 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
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 PTCFTCHTC lymph node metastases The secondary objectives are to evaluate the feasibility of MFGS for PTCFTCHTC 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 PTCFTCHTC 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 PTCFTCHTC for which the best TBR dosage group in PTCFTCHTC nodal metastasis will be determined The study will initiate with a 3 x 3 scheme 45 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None