Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03405142|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Procedure: Computed Tomography Procedure: Lymphoscintigraphy Drug: Panitumumab-IRDye800 Other: Pharmacological Study Procedure: Single Photon Emission Computed Tomography Radiation: Technetium Tc 99m-labeled Tilmanocept||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:||Single Group 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|
|Estimated Study Start Date :||July 16, 2018|
|Estimated Primary Completion Date :||January 12, 2020|
|Estimated Study Completion Date :||July 13, 2020|
Experimental: Diagnostic (panitumumab IRDye800, Lymphoseek)
Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 IV over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and SPECT/CT.
Procedure: Computed Tomography
Other: Pharmacological Study
Procedure: Single Photon Emission Computed Tomography
Radiation: Technetium Tc 99m-labeled Tilmanocept
Given via injection
- 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. The matched pair Durkalski's test accounting for the cluster-correlation within patient, for all sensitivity and specificity comparisons using the clust.bin.pair package in the R statistical software will be used. 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. Descriptive
- 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 as the gold standard will be calculated, and compared to neck dissection with Durkalski's test. Since false negatives are of particular concern, the odds of obtaining a false negative using panitumumab-IRDye800 relative to the odds of obtaining a false negative using Lymphoseek-based sentinel node biopsy will be
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||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Nick Oberhelman 650-724-3866 email@example.com|
|Principal Investigator: Eben L. Rosenthal|
|Principal Investigator:||Eben Rosenthal||Stanford Cancer Institute Palo Alto|