Trial Outcomes & Findings for Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer (NCT NCT03405142)

Last Updated: 2022-11-10

Results Overview

After administration of panitumumab-IRDye800 alone or with Lymphoseek, lymph nodes potentially containing malignant tumor cells were surgically removed, and the lymph node tissue was evaluated for panitumumab-IRDye800 fluorescence intensity. For each subject, the 5 lymph nodes with the strongest fluorescence signal were tabulated against the Lymphoseek and histopathologic findings for those specific lymph nodes. For each of the 3 modalities, a positive finding is considered indicative of malignancy. The outcome is reported as the number of positive findings by modality for each cohort. The outcome is a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2022-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	T1 or T2 Stage and Node-negative T1 or T2 stage primary tumor and node-negative (ie, cN0) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose. Lymphoseek: Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution	Any T Stage and Node-positive Any T stage tumor and node-positive (ie, cN+) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 30 days

Outcome measures

Outcome measures
Measure	T1 or T2 Stage and Node-negative n=10 Lymph nodes T1 or T2 stage primary tumor and node-negative (ie, cN0) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose. Lymphoseek: Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution	Any T Stage and Node-positive n=5 Lymph nodes Any T stage tumor and node-positive (ie, cN+) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.
Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800 Panitumumab-IRDye800	10 Lymph nodes	5 Lymph nodes
Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800 Lymphoseek	3 Lymph nodes	NA Lymph nodes Lymphoseek not administered to this cohort.
Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800 Histopathology	2 Lymph nodes	0 Lymph nodes

Adverse Events

T1 or T2 Stage and Node-negative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Any T Stage and Node-positive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roan Courtney Raymundo

Stanford Medicine at Stanford University

Phone: 650-721-4071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	T1 or T2 Stage and Node-negative n=2 Participants T1 or T2 stage primary tumor and node-negative (ie, cN0) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose. Lymphoseek: Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution	Any T Stage and Node-positive n=1 Participants Any T stage tumor and node-positive (ie, cN+) Panitumumab-IRDye800: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is \< 1/12 of the therapeutic dose.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	76.5 years n=5 Participants	61.6 years n=7 Participants	71.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants