Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures
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ClinicalTrials.gov Identifier: NCT01987375 |
Recruitment Status :
Terminated
(logistics)
First Posted : November 19, 2013
Last Update Posted : June 24, 2019
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Condition or disease | Intervention/treatment | Phase |
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Head and Neck Cancer | Drug: Cetuximab-IRDye800 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Cancer During Surgical Procedures |
Study Start Date : | November 2015 |
Actual Primary Completion Date : | April 19, 2017 |
Actual Study Completion Date : | April 19, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Cetuximab-IRDye800 Participants
Participants who received the study drug cetuximab-IRDye800, following a loading dose of unlabeled cetuximab
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Drug: Cetuximab-IRDye800
a single dose of the study drug following a single loading dose of unlabeled cetuximab |
- Number of subjects in a cohort experiencing a DLT (gr 2 or greater AE considered at least possibly related to study drug & clinically significant by the PI) after receiving cetuximab conjugated to the optical dye IRDye800CW(cetuximab-IRDye800) [ Time Frame: 30 days post intervention ]
- Number of subjects with identifiable cancer as compared to surrounding normal tissue by correlating fluorescence with histological evidence of tumor post receipt of cetuximab conjugated to the optical dye, IRDye800CW (cetuximab-IRDye800) [ Time Frame: One year post intervention ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
- Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Age ≥ 19 years
- Have life expectancy of more than 12 weeks
- Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
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Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9gm/dL
- Platelet count ≥ 100,000/mm3
- Magnesium, potassium and calcium greater than or equal than the lower limit of normal range per institution normal lab values
- TSH <10 micro International Units/mL
Exclusion Criteria:
- Received an investigational drug within 30 days prior to first dose of cetuximab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, uncontrolled CHF, significant liver disease, unstable angina
- Inadequately controlled hypertension with or without current antihypertensive medications
- History of infusion reactions to cetuximab or other monoclonal antibody therapies.
- Women who are pregnant or breast feeding
- Patients who have a grade 2 or greater reaction with the test/loading cetuximab dose.
- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females).
- Lab values that in the opinion of the primary surgeon would prevent surgical resection.
- Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Patients with TSH>11

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): NCT01987375
United States, California | |
Stanford University, School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Eben Rosenthal, MD | Stanford University |
Responsible Party: | Eben Rosenthal, Professor of Otolaryngology, Stanford University |
ClinicalTrials.gov Identifier: | NCT01987375 |
Other Study ID Numbers: |
IRB-35068 ENT0049 ( Other Identifier: OnCore ) |
First Posted: | November 19, 2013 Key Record Dates |
Last Update Posted: | June 24, 2019 |
Last Verified: | June 2019 |
HNSCC Imaging |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |