Trial Outcomes & Findings for Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery (NCT NCT02736578)

Last Updated: 2019-06-25

Results Overview

Cetuximab-IRDye800 (50 mg or 100 mg) was administered pre-operatively, and the uptake of the dye was assessed by observed fluorescence intra-operatively (ie, in vivo) and post-operatively (ex vivo, or "back table"), in tumorous (tumor or tumor-bearing lymph nodes) or normal (non-tumorous) tissues. Collectively, intra-operative and immediately post-operative are considered "peri-operative." The outcome tumor-to-background ratio (TBR) is measured as the mean of the ratios observed between tumor and normal tissue for the participants, and the outcome is expressed as the mean with standard deviation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

up to 5 days

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab IRDye800, 50 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Overall Study STARTED	6	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab IRDye800, 50 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Overall Study Adverse Event	1	0

Baseline Characteristics

Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to 5 days

Population: Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort in order to reduce variance/dispersion.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=6 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses In vivo (tumor at resection)	2.3 ratio Standard Deviation 0.72	—	—
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses In vivo (lymph node at resection)	6.3 ratio Standard Deviation 0.82	—	—
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses Ex vivo (post-operative, back-table)	3.4 ratio Standard Deviation 0.4	—	—

SECONDARY outcome

Timeframe: up to 14 days

Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean counts/pixel for the cohort. The outcome is expressed as the mean counts/pixel with standard deviation.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=6 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo) Normal pancreatic tissue	0.02 counts per pixel Standard Deviation 0.01	—	—
Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo) Pancreatitis tissue	0.04 counts per pixel Standard Deviation 0.02	—	—
Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo) Pancreatic tumor tissue	0.09 counts per pixel Standard Deviation 0.06	—	—

SECONDARY outcome

Timeframe: up to 14 days

Population: Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants.

Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as a mean with standard deviation, by dose.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=4 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=2 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity Normal pancreatic tissue	0.02 counts per pixel Standard Deviation 0.01	0.03 counts per pixel Standard Deviation 0.02	—
Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity Pancreatitis tissue	0.03 counts per pixel Standard Deviation 0.02	0.06 counts per pixel Standard Deviation 0.03	—
Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity Pancreatic tumor tissue	0.09 counts per pixel Standard Deviation 0.06	0.10 counts per pixel Standard Deviation 0.05	—

SECONDARY outcome

Timeframe: up to 14 days

Population: Outcome results for sensitivity and specificity of fluorescent imaging were available by dose, and compiled across both doses. Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants.

Sensitivity is the ability of a test to correctly identify patients with the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-positive patients. Sensitivity is defined as \[TP/(TP+FN)\], where TP=true-positive, and FN=false-negative. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result. Specificity is the ability of a test to correctly identify patients who do not have the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-negative patients. Specificity is defined as \[TN/(TN+FP)\], where TN=true-negative, and FP=false-positive. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=72 Lymph nodes On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=72 Lymph nodes On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses n=144 Lymph nodes On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Sensitivity and Specificity of Ex Vivo Fluorescent Imaging Sensitivity	100.0 percentage of lymph nodes	88.2 percentage of lymph nodes	96.1 percentage of lymph nodes
Sensitivity and Specificity of Ex Vivo Fluorescent Imaging Specificity	78.0 percentage of lymph nodes	32.1 percentage of lymph nodes	67.0 percentage of lymph nodes

SECONDARY outcome

Timeframe: up to 14 days

Population: The relationship of the number of participants to number of analyzed lymph nodes (tumor-bearing or not) is not 1:1, \& tissue sampling \& labeling are imprecise. Participants could contribute none or multiple normal and tumor-bearing lymph node for analysis. Data were not obtained for all participants.

Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in excised lymph nodes (ie, ex vivo) that were histologically-determined to be normal or tumor-bearing. Fluorescent intensity was measured in the image for each lymph using close-field fluorescence imaging and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as the mean MFI with standard deviation.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=72 Lymph nodes On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=72 Lymph nodes On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Cetuximab-IRDye800 Tumor Detection in Lymph Nodes Tumor-bearing lymph nodes	0.071 counts per pixel Standard Error 0.01	0.046 counts per pixel Standard Error 0.007	—
Cetuximab-IRDye800 Tumor Detection in Lymph Nodes Histologically normal lymph nodes	0.018 counts per pixel Standard Error 0.001	0.035 counts per pixel Standard Error 0.004	—

SECONDARY outcome

Timeframe: up to 5 days

Population: Tissue sampling and labeling can be imprecise. Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort. Data were not obtained for all participants. Dispersion was not and can not be determined for the outcome, a ratio (ratio of means).

Photoacoustics were assessed as the signal-to-noise ratio (SNR), a unit-less number, as observed for tumor vs surrounding tissue using an ultrasound device. The value observed for tumor tissue is considered signal, and the value for normal tissue is considered noise. The more the ratio is greater than 1 reflects the more that the tumor tissue reflects an ultrasound signal compared to normal tissue. The outcome is expressed as the ratio of mean SNR signal for tumor tissue to normal tissue, without dispersion.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=4 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI)	3.7 ratio	—	—

SECONDARY outcome

Timeframe: up to 5 days

Population: The in vivo photoacoustic imaging (PAI) component of this study was not IRB-approved, and this part of the study was not conducted.

Photoacoustic imaging (PAI) was to be used to evaluate tumor and normal margin tissues (waste tissue) immediately peri-operatively (in vivo) and prior to pathological evaluation. The signal-to-noise ratio (SNR) as measured in dB of the tumor was to be calculated in the tumor specimens for comparison to surrounding normal tissue. The outcome would be expressed as the mean of the ratios, with standard deviation, and data used to qualitatively confirm the findings with Cetuximab-IRDye 800CW fluorescent imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days

Toxicity was assessed as the number of grade 2 or greater adverse events \[Common Terminology Criteria for Adverse Events (CTCAE) version 4.03\] determined to be clinically-significant and definitely-, probably-, or possibly-related to cetuximab-IRDye 800CW. The outcome is reported as the number of treatment-related adverse events ≥ grade 2 without dispersion, by dose level.

Outcome measures

Outcome measures
Measure	Cetuximab IRDye800, 50 mg n=6 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=2 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, Both Doses On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or at 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Toxicity (≥ Grade 2)	1 Adverse events	0 Adverse events	—

Adverse Events

Cetuximab IRDye800, 50 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Cetuximab IRDye800, 100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab IRDye800, 50 mg n=6 participants at risk On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=2 participants at risk On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Gastrointestinal disorders Pancreatic fistula	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week

Other adverse events

Other adverse events
Measure	Cetuximab IRDye800, 50 mg n=6 participants at risk On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=2 participants at risk On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose
Blood and lymphatic system disorders Anemia	83.3% 5/6 • Number of events 16 • 30 days +- one week	100.0% 2/2 • Number of events 3 • 30 days +- one week
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 2 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Number of events 2 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Gastrointestinal disorders Ileus	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
General disorders Fever	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
General disorders Pain	50.0% 3/6 • Number of events 4 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations Blood bilirubin increased	50.0% 3/6 • Number of events 4 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Investigations Activated partial thromboplastin time prolonged	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations Alanine aminotransferase increased	83.3% 5/6 • Number of events 10 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Investigations Alkaline phosphatase increased	66.7% 4/6 • Number of events 5 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Investigations Aspartate aminotransferase increased	83.3% 5/6 • Number of events 12 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Investigations Creatinine increased	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations Electrocardiogram QT corrected interval prolonged	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations INR increased	33.3% 2/6 • Number of events 2 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations Lymphocyte count decreased	33.3% 2/6 • Number of events 4 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Investigations Weight loss	33.3% 2/6 • Number of events 3 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Metabolism and nutrition disorders Acidosis	33.3% 2/6 • Number of events 3 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 10 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Metabolism and nutrition disorders Hyperkalemia	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Metabolism and nutrition disorders Hypermagnesemia	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Metabolism and nutrition disorders Hypoalbuminemia	83.3% 5/6 • Number of events 19 • 30 days +- one week	50.0% 1/2 • Number of events 2 • 30 days +- one week
Metabolism and nutrition disorders Hypocalcemia	83.3% 5/6 • Number of events 19 • 30 days +- one week	100.0% 2/2 • Number of events 3 • 30 days +- one week
Metabolism and nutrition disorders Hypokalemia	66.7% 4/6 • Number of events 7 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Metabolism and nutrition disorders Hypomagnesemia	33.3% 2/6 • Number of events 3 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Metabolism and nutrition disorders Hyponatremia	66.7% 4/6 • Number of events 9 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Metabolism and nutrition disorders Hypophosphatemia	66.7% 4/6 • Number of events 10 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Renal and urinary disorders Urinary retention	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Surgical and medical procedures Surgical and medical procedures - Other, specify	33.3% 2/6 • Number of events 3 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Vascular disorders Hypertension	66.7% 4/6 • Number of events 9 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Renal and urinary disorders Urinary frequency	0.00% 0/6 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • 30 days +- one week	50.0% 1/2 • Number of events 1 • 30 days +- one week
Immune system disorders Allergic reaction	16.7% 1/6 • Number of events 1 • 30 days +- one week	0.00% 0/2 • 30 days +- one week

Additional Information

Eben Rosenthal

Stanford University

Phone: 650-723-2967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cetuximab IRDye800, 50 mg n=6 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Cetuximab IRDye800, 100 mg n=2 Participants On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose	Total n=8 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	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 7.9 • n=5 Participants	70.4 years STANDARD_DEVIATION 7.1 • n=7 Participants	65.2 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants