CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
Panitumumab-IRDye800 +1 moredrug
Likely dose
Panitumumab-IRDye800 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03405142
NCT03405142Phase 2Completed

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

Eben Rosenthal·interventional·Posted Jan 19, 2018·Updated Nov 10, 2022

In Brief

A Phase 2 clinical trial evaluating Panitumumab-IRDye800 and Lymphoseek for Head and Neck Squamous Cell Carcinoma and 2 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 19, 2018
Enrollment StartAug 1, 2019
Primary CompletionDec 4, 2019
Study CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.5 years ago

Interventions

Panitumumab-IRDye800drug

Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.

Lymphoseekdrug

Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution