Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03405142|
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: Panitumumab-IRDye800 Drug: Lymphoseek||Phase 2|
I. To determine if near-infrared fluorescence imaging of panitumumab-IRDye800 can identify metastatic disease in regional neck lymph nodes of patients with head and neck squamous cell carcinoma (HNSCC).
I. Determine if panitumumab-IRDye800 can identify sentinel nodes with the same accuracy as technetium Tc 99m-labeled tilmanocept (Lymphoseek).
Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 intravenously (IV) over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and single photon emission computed tomography/computed tomography (SPECT/CT).
After completion of study, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: T1 or T2 stage and node negative
T1 or T2 stage primary tumor and node negative (i.e., cN0)
50 mg infusion
2 mCi, infusion
Experimental: Any T stage and node positive
Any T stage tumor and node positive (i.e., cN+)
50 mg infusion
- Number and location of panitumumab-IRDye800 positive lymph nodes (LNs) that are also tumor- positive at (histo-) pathology [ Time Frame: Up to 30 days ]The sensitivity and specificity of the intraoperative findings on whether the LN is fluorescent (i.e. presence of panitumumab-IRDye800) to the histopathological status of the LNs will be calculated. Significance for both primary and secondary analyses will be assessed at the 0.05 level and to assess uncertainty, 95% confidence intervals will be provided for all estimates.
- The number and location of Lymphoseek positive lymph nodes (LNs) that are also tumor-positive at (histo-) pathology [ Time Frame: Up to 30 days ]Whether the LN tracer Lymphoseek can identify metastatic disease in regional neck LNs of patients with head and neck squamous cell cancer will be determined. Similar to the primary analysis, the specificity and sensitivity of Lymphoseek for metastatic LN identification, using histology will be calculated, and compared to neck dissection with Durkalski's test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405142
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Grace Yi 650-723-0387 email@example.com|
|Principal Investigator: Fred M Baik|
|Principal Investigator:||Fred M Baik||Stanford Cancer Institute Palo Alto|