Squamous Cell Carcinoma of the Head and NeckPhase 1NCT03733210
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
A Phase 1 study testing Panitumumab-IRDye800, 89-Zirconium (Zr-89) Panitumumab and Pinpoint IR IR9000 fluorescence imaging system (FIS) in people with Squamous Cell Carcinoma of the Head and Neck and Carcinoma of the Head and Neck, run by Andrei Iagaru at 1 site in United States.
Trial summary
This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck, Carcinoma of the Head and Neck
- What is being tested?
- Panitumumab-IRDye800, 89-Zirconium (Zr-89) Panitumumab and Pinpoint IR IR9000 fluorescence imaging system (FIS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 9 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma.
- Hemoglobin ≥ 9 gm/dL.
- White blood cell count > 3000/mm³.
- Platelet count ≥ 100,000/mm³.
- Serum creatinine ≤ 1.5 times upper reference range.
Who cannot join
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Previous bilateral neck dissection.
- History of infusion reactions to monoclonal antibody therapies.
- Pregnant or breastfeeding.
- Magnesium or potassium lower than the normal institutional values.
- Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Show all 9Show fewer
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
- Known hypersensitivity to deferoxamine or any of its components.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
About this study
Official title: Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer
This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods [positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].
Read the detailed description
For patients with head and neck cancer, detection of malignant cells within nearby lymph nodes (LNs) is an important measure of the extent and severity of the cancer. LNs are a key immunologic organ involved in overall immune surveillance. Historically, LN or LNs were harvested before the surgery of curative intent, evaluated pathologically, and then tumor status of the harvested LNs were utilized to inform the individual surgical plan. These LNs became known as "sentinel lymph nodes." In recent years, techniques have been developed to utilize peritumoral injection (around the tumor) of tumor labels that could identify tumor in the LNs without biopsy, ie, only LNs that were tumor-positive would be removed. However, in some patients, this technique could be limited by the location of the primary cancer. Effective and sensitive systemically-administered labels would be a significant advancement. The systemically-administered label 18F-fluorodeoxyglucose (18F-FDG), detected by positron emission tomography / computed tomography (PET/CT) and/or PET / magnetic imaging resonance (PET/MRI) radiologic scans and representing current regular medical care, has provided improvement in detection of cancer-positive LNs. However, further enhancements may be possible.
Participants with squamous cell carcinoma of the head and neck (SCCHN) and scheduled to undergo regular medical care surgery with curative intent, were assigned to 2 study groups on the basis of whether regular medical care scans using 18F-FDG PET/CT or PET/MRI had indicated that cancer was suspected in the lymph nodes (LN+ or cN+), or without suspected cancer in the lymph nodes (LN- or cN0). Following the 18F-FDG, and prior to surgery, 89Zr-panitumumab was systemically administered by intravenous infusion, and a PET-CT imaging scan was conducted. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. Regular medical care surgical excision of the tumor and adjacent LN was conducted on Day 2 to 5. After surgery, patients are followed up at 15 and 30 days.
PRIMARY OBJECTIVES:
- Determine the sensitivity and specificity of zirconium(89Zr)-panitumumab (89Zr-panitumumab) for the detection of tumor-involved regional lymph nodes.
SECONDARY OBJECTIVES:
- Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr-panitumumab labeling.
EXPLORATORY OBJECTIVES:
- Determine the sensitivity and specificity of panitumumab-IRDye800 for the detection of tumor-involved regional lymph nodes.
II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRDye800 labeling.
- Being tested
- Panitumumab-IRDye800, 89-Zirconium (Zr-89) Panitumumab, Pinpoint IR IR9000 fluorescence imaging system (FIS), SPY-PHI IR9000 fluorescence imaging system (FIS), Explorer Air camera
- Keywords
- Head and Neck Cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab-IRDye800Drug
Also called Panitumumab IRDye 800, IRDye800-Panitumumab Conjugate
30 mg administered intravenously (IV)
89-Zirconium (Zr-89) PanitumumabDrug
Also called 89Zr-panitumumab (SY), 89Zr-labeled Panitumumab (SY), Zr 89-Panitumumab (SY)
0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)
Pinpoint IR IR9000 fluorescence imaging system (FIS)Device
Handheld fluorescence-imaging endoscope manufactured by Novadaq
SPY-PHI IR9000 fluorescence imaging system (FIS)Device
Handheld fluorescence-imaging endoscope manufactured by Novadaq
Explorer Air cameraDevice
Fluorescence camera manufactured by SurgVision
PDE-NEO II cameraDevice
Medical infrared camera manufactured by Hamamatsu Photonics KK
FIS-00 fluorescence imaging system (FIS)Device
Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK
Da Vinci Firefly Imaging SystemDevice
Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc
IGP-ELVIS-v4 Macroscopic Specimen ImagerDevice
Macroscopic specimen imager manufactured by LI-COR Biosciences
Vevo 3100 LAZR-XDevice
Photoacoustic ultrasound imaging system manufactured by VisualSonics
Pearl Triology Imaging SystemDevice
Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences
Odyssey CLx Imaging SystemDevice
Infrared fluorescent-imaging system manufactured by LI-COR Biosciences
Leica fluorescence microscopeDevice
Fluorescence microscope manufactured by Leica
| Study group | Role | What they receive |
|---|---|---|
| Tumor-negative Lymph Nodes (by 18F-FDG scan) | Experimental | Participants whose lymph nodes are negative for cancer Receives: Drug: Panitumumab-IRDye800; Drug: 89-Zirconium (Zr-89) Panitumumab; Device: Pinpoint IR IR9000 fluorescence imaging system (FIS); Device: SPY-PHI IR9000 fluorescence imaging system (FIS); Device: Explorer Air camera; Device: PDE-NEO II camera; Device: FIS-00 fluorescence imaging system (FIS); Device: Da Vinci Firefly Imaging System; Device: IGP-ELVIS-v4 Macroscopic Specimen Imager; Device: Vevo 3100 LAZR-X; Device: Pearl Triology Imaging System; Device: Odyssey CLx Imaging System; Device: Leica fluorescence microscope |
| Tumor-positive Lymph Nodes (by 18F-FDG scan) | Experimental | Participants whose lymph nodes are positive for cancer. Receives: Drug: Panitumumab-IRDye800; Drug: 89-Zirconium (Zr-89) Panitumumab; Device: Pinpoint IR IR9000 fluorescence imaging system (FIS); Device: SPY-PHI IR9000 fluorescence imaging system (FIS); Device: Explorer Air camera; Device: PDE-NEO II camera; Device: FIS-00 fluorescence imaging system (FIS); Device: Da Vinci Firefly Imaging System; Device: IGP-ELVIS-v4 Macroscopic Specimen Imager; Device: Vevo 3100 LAZR-X; Device: Pearl Triology Imaging System; Device: Odyssey CLx Imaging System; Device: Leica fluorescence microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling
The ability of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG) to detect tumor in lymph nodes were assessed on the basis of radiologic scans and histopathologic evaluation of excised lymph nodes (LNs). The histopathologic assessment was considered the definitive, regular medical care, assessment. The outcome is reported by study group as the number of LNs that were identified as tumor-positive by 18F-FDG- and 89Zr-panitumumab, stratified by the tumor-positivity as assessed by histopathology, and expressed as the number of LNs that were tumor-positive by both, negative for both, or positive for one and not the other. Results are also provided by study group for the number of LNs that tumor-positive by both 18F-FDG- and 89Zr-panitumumab, negative for both, or positive for one and not the other. The outcome is numbers without dispersion
Measured: up to 5 days
Secondary outcomes (1)
Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800
The value of 89Zr-panitumumab and panitumumab-IRDye800 as a label for cancer cells (radiologic or fluorescent, respectively), was assessed by the sensitivity and specificity for the detection of tumor cells in lymph nodes near the tumor. 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use, was also assessed. Sensitivity was assessed as the "true positive rate" of paired measurements, expressed as the proportion (ratio) of the number of specimens positive by histopathology also positive by the test method (test:histopathology). Specificity is the "true negative rate", the proportion of the number of specimens negative by histopathology also negative by the test method. The closer the proportions are to 1, the greater the sensitivity or specificity. The outcome is reported as the sensitivity and specificity of 89Zr-panitumumab, panitumumab-IRDye800, and 18F-fluorodeoxyglucose (18F-FDG). The outcome results are ratios, a number without dispersion.
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start7 Jan 2019
- Primary completion11 Dec 2020
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, MD, Principal investigator, Stanford Medicine at Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733210
- Sponsor's protocol ID
- IRB-41878
- Other IDs
- NCI-2018-02270, ENT0066, P30CA124435, R01CA190306
- Status last verified
- Apr 2023
- First submitted
- 5 Nov 2018
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03733210
- Acronym / sponsor ID
- IRB-41878
- Keywords
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods [positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].
Detailed description
For patients with head and neck cancer, detection of malignant cells within nearby lymph nodes (LNs) is an important measure of the extent and severity of the cancer. LNs are a key immunologic organ involved in overall immune surveillance. Historically, LN or LNs were harvested before the surgery of curative intent, evaluated pathologically, and then tumor status of the harvested LNs were utilized to inform the individual surgical plan. These LNs became known as "sentinel lymph nodes." In recent years, techniques have been developed to utilize peritumoral injection (around the tumor) of tumor labels that could identify tumor in the LNs without biopsy, ie, only LNs that were tumor-positive would be removed. However, in some patients, this technique could be limited by the location of the primary cancer. Effective and sensitive systemically-administered labels would be a significant advancement. The systemically-administered label 18F-fluorodeoxyglucose (18F-FDG), detected by positron emission tomography / computed tomography (PET/CT) and/or PET / magnetic imaging resonance (PET/MRI) radiologic scans and representing current regular medical care, has provided improvement in detection of cancer-positive LNs. However, further enhancements may be possible.
Participants with squamous cell carcinoma of the head and neck (SCCHN) and scheduled to undergo regular medical care surgery with curative intent, were assigned to 2 study groups on the basis of whether regular medical care scans using 18F-FDG PET/CT or PET/MRI had indicated that cancer was suspected in the lymph nodes (LN+ or cN+), or without suspected cancer in the lymph nodes (LN- or cN0). Following the 18F-FDG, and prior to surgery, 89Zr-panitumumab was systemically administered by intravenous infusion, and a PET-CT imaging scan was conducted. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. Regular medical care surgical excision of the tumor and adjacent LN was conducted on Day 2 to 5. After surgery, patients are followed up at 15 and 30 days.
PRIMARY OBJECTIVES:
- Determine the sensitivity and specificity of zirconium(89Zr)-panitumumab (89Zr-panitumumab) for the detection of tumor-involved regional lymph nodes.
SECONDARY OBJECTIVES:
- Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr-panitumumab labeling.
EXPLORATORY OBJECTIVES:
- Determine the sensitivity and specificity of panitumumab-IRDye800 for the detection of tumor-involved regional lymph nodes.
II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRDye800 labeling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor-negative Lymph Nodes (by 18F-FDG scan) | Experimental | Drug: Panitumumab-IRDye800, Drug: 89-Zirconium (Zr-89) Panitumumab, Device: Pinpoint IR IR9000 fluorescence imaging system (FIS), Device: SPY-PHI IR9000 fluorescence imaging system (FIS), Device: Explorer Air camera, Device: PDE-NEO II camera, Device: FIS-00 fluorescence imaging system (FIS), Device: Da Vinci Firefly Imaging System, Device: IGP-ELVIS-v4 Macroscopic Specimen Imager, Device: Vevo 3100 LAZR-X, Device: Pearl Triology Imaging System, Device: Odyssey CLx Imaging System, Device: Leica fluorescence microscopeParticipants whose lymph nodes are negative for cancer |
| Tumor-positive Lymph Nodes (by 18F-FDG scan) | Experimental | Drug: Panitumumab-IRDye800, Drug: 89-Zirconium (Zr-89) Panitumumab, Device: Pinpoint IR IR9000 fluorescence imaging system (FIS), Device: SPY-PHI IR9000 fluorescence imaging system (FIS), Device: Explorer Air camera, Device: PDE-NEO II camera, Device: FIS-00 fluorescence imaging system (FIS), Device: Da Vinci Firefly Imaging System, Device: IGP-ELVIS-v4 Macroscopic Specimen Imager, Device: Vevo 3100 LAZR-X, Device: Pearl Triology Imaging System, Device: Odyssey CLx Imaging System, Device: Leica fluorescence microscopeParticipants whose lymph nodes are positive for cancer. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma.
- Hemoglobin ≥ 9 gm/dL.
- White blood cell count > 3000/mm³.
Key exclusion criteria (9 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Previous bilateral neck dissection.
- History of infusion reactions to monoclonal antibody therapies.
- Pregnant or breastfeeding.
- Magnesium or potassium lower than the normal institutional values.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panitumumab-IRDye800Also: Panitumumab IRDye 800, IRDye800-Panitumumab Conjugate30 mg administered intravenously (IV) | Drug | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| 89-Zirconium (Zr-89) PanitumumabAlso: 89Zr-panitumumab (SY), 89Zr-labeled Panitumumab (SY), Zr 89-Panitumumab (SY)0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) | Drug | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Pinpoint IR IR9000 fluorescence imaging system (FIS)Handheld fluorescence-imaging endoscope manufactured by Novadaq | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| SPY-PHI IR9000 fluorescence imaging system (FIS)Handheld fluorescence-imaging endoscope manufactured by Novadaq | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Explorer Air cameraFluorescence camera manufactured by SurgVision | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| PDE-NEO II cameraMedical infrared camera manufactured by Hamamatsu Photonics KK | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| FIS-00 fluorescence imaging system (FIS)Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Da Vinci Firefly Imaging SystemFluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| IGP-ELVIS-v4 Macroscopic Specimen ImagerMacroscopic specimen imager manufactured by LI-COR Biosciences | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Vevo 3100 LAZR-XPhotoacoustic ultrasound imaging system manufactured by VisualSonics | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Pearl Triology Imaging SystemNear-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Odyssey CLx Imaging SystemInfrared fluorescent-imaging system manufactured by LI-COR Biosciences | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
| Leica fluorescence microscopeFluorescence microscope manufactured by Leica | Device | Tumor-negative Lymph Nodes (by 18F-FDG scan), Tumor-positive Lymph Nodes (by 18F-FDG scan) |
Primary outcome
Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling
Time frame: up to 5 days
The ability of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG) to detect tumor in lymph nodes were assessed on the basis of radiologic scans and histopathologic evaluation of excised lymph nodes (LNs). The histopathologic assessment was considered the definitive, regular medical care, assessment. The outcome is reported by study group as the number of LNs that were identified as tumor-positive by 18F-FDG- and 89Zr-panitumumab, stratified by the tumor-positivity as assessed by histopathology, and expressed as the number of LNs that were tumor-positive by both, negative for both, or positive for one and not the other. Results are also provided by study group for the number of LNs that tumor-positive by both 18F-FDG- and 89Zr-panitumumab, negative for both, or positive for one and not the other. The outcome is numbers without dispersion
1 secondary outcome
Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800
Time frame: up to 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Iagaru, MD principal investigator
Stanford Medicine at Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Panitumumab-IRDye800, 89-Zirconium (Zr-89) Panitumumab and Pinpoint IR IR9000 fluorescence imaging system (FIS) in people with Squamous Cell Carcinoma of the Head and Neck and Carcinoma of the Head and Neck, run by Andrei Iagaru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.