Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540443
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging MRI for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the safety and effectiveness of MPB-2043 a superparamagnetic iron oxide SPIO contrast agent for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer The study compares four doses of MPB-2043 05 mgkg 1 mgkg 2 mgkg and 3 mgkg and assesses the optimal timing for post-dose imaging using T1T2T2-weighted sequences to improve the accuracy of nodal staging
Detailed Description:
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast Superparamagnetic iron oxide SPIO particles such as MPB-2043 have shown promise as MRI contrast agents particularly in the detection of metastatic lesions in the liver This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes
In this study T1T2T2-weighted MRI sequences will be used to assess signal intensity SI changes in lymph nodes after the administration of MPB-2043 The susceptibility effects of the iron oxide core cause tissue signal loss which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system allowing for differentiation from malignant lymph nodes The study will evaluate the safety and effectiveness of four different doses of MPB-2043 05 mgkg 1 mgkg 2 mgkg and 3 mgkg in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas
In this study T1T2T2-weighted MRI sequences will be used to assess signal intensity SI changes in lymph nodes after the administration of MPB-2043 The susceptibility effects of the iron oxide core cause tissue signal loss which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system allowing for differentiation from malignant lymph nodes The study will evaluate the safety and effectiveness of four different doses of MPB-2043 05 mgkg 1 mgkg 2 mgkg and 3 mgkg in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None