Pancreatic AdenocarcinomaPhase 2NCT02736578
Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery
A Phase 2 study testing Cetuximab-IRDye800 and Cetuximab in people with Pancreatic Adenocarcinoma, run by Eben Rosenthal at 1 site in United States.
Trial summary
This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Cetuximab-IRDye800 and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 22 May 2017
- Phase
- Phase 2
- 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
- Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
- Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
- ≥ 19 years of age
- Life expectancy of more than 12 weeks
- EITHER
- Karnofsky performance status of at least 70%, OR
Show all 13Show fewer
- Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
- Hemoglobin ≥ 9 gm/dL
- Platelet count ≥ 100,000/mm^3
- Magnesium > the lower limit of normal (LLN) per institution normal lab values
- Potassium > LLN
- Calcium > LLN
- Thyroid-stimulating hormone (TSH) < 13 micro International units/mL
Who cannot join
- Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of QT prolongation on pretreatment electrocardiography (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, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94304
About this study
Official title: Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging
This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.
Read the detailed description
This is a dose-escalation study of 50 mg or 100 mg cetuximab-IRDye800.
Clearance of the tumor margin during surgical resection of pancreatic cancer is clinical importance, as margin-positive resections are suspected to be associated with rapid emergence of distant metastases shortly after surgery. However, pancreatic cancer is known to be difficult to visualize intraoperatively. Nonetheless, better detection of tumor tissue might improve the rate of complete tumor clearance, thereby improving outcomes. However, in order to be actionable, the data from such enhanced tumor detection must be available during the resection procedure. This study evaluates the use of a dye, Cetuximab-IRDye 800CW, that is administered pre-surgery, and is detectable during the surgical procedure.
Florescent Imaging Cetuximab is a chimeric (mouse/human) monoclonal antibody that targets the epidermal growth factor (EGF) receptor (EGFR). EGFR is highly-expressed in pancreatic ductal adenocarcinoma (PDAC) and is a good target for antibody-mediated imaging, due to its transmembrane position. Cetuximab-IRDye 800CW is cetuximab labeled with IRDye800, an N-hydroxysuccinimide (NHS) ester infrared dye. IRDye800 has very similar properties compared to indocyanine green, and indocyanine green is readily detectable with a number of imaging systems. This study evaluates the Cetuximab-IRDye 800CW as a intraoperative labeling agent.
Patients receive Cetuximab-IRDye 800CW intravenously (IV) at 50 mg or 100 mg over 30 minutes to 1 hour on day 0. Within 2 to 5 days, patients undergo surgery with intraoperative imaging. Cetuximab-IRDye 800CW is used as part of a tumor-targeted molecular imaging procedure operating on the principles of differential accumulation of the antibody-dye conjugate in pancreatic tumor tissue vs normal pancreatic tissue vs pancreatitis tissue.
Excised tissues are prepared as formalin-fixed paraffin-embedded (FFPE) blocks for assessment of fluorescent intensity.
Photoacoustic imaging (PAI) For purposes of non-quantitative comparison, photoacoustic imaging (PAI) of the tumor lesions is also conducted. PAI refers to a non-invasive evaluation by ultrasound of the area of the resected tumor and surrounding tissue. PAI may have special utility for detecting tumors within 5 to 7 mm of depth, with a high degree of spatial resolution, which might be useful to enhance generation of tumor-free surgical margins. PAI does not utilize ionizing radiation, and should complement and conform to the findings from the fluorescent imaging.
PRIMARY OBJECTIVE:
Determine the efficacy of cetuximab-IRDye800 in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.
SECONDARY OBJECTIVE:
Determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Cetuximab-IRDye800, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab-IRDye800Drug
Also called Cetuximab-IRDye 800CW
Administered intravenously (IV) at 50 or 100 mg
CetuximabDrug
Also called Erbitux, C225
Administered as a 100 mg IV loading dose
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab IRDye800, 50 mg | Experimental | 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. Receives: Drug: Cetuximab-IRDye800; Drug: Cetuximab |
| Cetuximab IRDye800, 100 mg | Experimental | 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. Receives: Drug: Cetuximab-IRDye800; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses
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.
Measured: up to 5 days
Secondary outcomes (7)
Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo)
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.
Measured: up to 14 days
Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity
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.
Measured: up to 14 days
Sensitivity and Specificity of Ex Vivo Fluorescent Imaging
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.
Measured: up to 14 days
Cetuximab-IRDye800 Tumor Detection in Lymph Nodes
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.
Measured: up to 14 days
Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI)
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.
Measured: up to 5 days
Signal-to-Noise Ratio (SNR) by In Vivo Photoacoustic Imaging (PAI)
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.
Measured: up to 5 days
Toxicity (≥ Grade 2)
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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion24 Apr 2017
- Study completion22 May 2017
Why it stopped: Logistics
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eben Rosenthal
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Eben Rosenthal, Stanford University
- Investigators
- George Poultsides, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736578
- Sponsor's protocol ID
- IRB-35789
- Other IDs
- NCI-2016-00433, PANC0024, P30CA124435
- Status last verified
- Jun 2019
- First submitted
- 4 Apr 2016
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenthal EL, Kulbersh BD, King T, Chaudhuri TR, Zinn KR. Use of fluorescent labeled anti-epidermal growth factor receptor antibody to image head and neck squamous cell carcinoma xenografts. Mol Cancer Ther. 2007 Apr;6(4):1230-8. doi: 10.1158/1535-7163.MCT-06-0741.
PubMed 17431103Rosenthal EL, Kulbersh BD, Duncan RD, Zhang W, Magnuson JS, Carroll WR, Zinn K. In vivo detection of head and neck cancer orthotopic xenografts by immunofluorescence. Laryngoscope. 2006 Sep;116(9):1636-41. doi: 10.1097/01.mlg.0000232513.19873.da.
PubMed 16954995Tummers WS, Miller SE, Teraphongphom NT, Gomez A, Steinberg I, Huland DM, Hong S, Kothapalli SR, Hasan A, Ertsey R, Bonsing BA, Vahrmeijer AL, Swijnenburg RJ, Longacre TA, Fisher GA, Gambhir SS, Poultsides GA, Rosenthal EL. Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging. Ann Surg Oncol. 2018 Jul;25(7):1880-1888. doi: 10.1245/s10434-018-6453-2. Epub 2018 Apr 17.
PubMed 29667116Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available.
PubMed 32416765
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging
- ClinicalTrials.gov ID
- NCT02736578
- Acronym / sponsor ID
- IRB-35789
- Conditions
- Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistics
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Eben RosenthalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2016
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.
Detailed description
This is a dose-escalation study of 50 mg or 100 mg cetuximab-IRDye800.
Clearance of the tumor margin during surgical resection of pancreatic cancer is clinical importance, as margin-positive resections are suspected to be associated with rapid emergence of distant metastases shortly after surgery. However, pancreatic cancer is known to be difficult to visualize intraoperatively. Nonetheless, better detection of tumor tissue might improve the rate of complete tumor clearance, thereby improving outcomes. However, in order to be actionable, the data from such enhanced tumor detection must be available during the resection procedure. This study evaluates the use of a dye, Cetuximab-IRDye 800CW, that is administered pre-surgery, and is detectable during the surgical procedure.
Florescent Imaging Cetuximab is a chimeric (mouse/human) monoclonal antibody that targets the epidermal growth factor (EGF) receptor (EGFR). EGFR is highly-expressed in pancreatic ductal adenocarcinoma (PDAC) and is a good target for antibody-mediated imaging, due to its transmembrane position. Cetuximab-IRDye 800CW is cetuximab labeled with IRDye800, an N-hydroxysuccinimide (NHS) ester infrared dye. IRDye800 has very similar properties compared to indocyanine green, and indocyanine green is readily detectable with a number of imaging systems. This study evaluates the Cetuximab-IRDye 800CW as a intraoperative labeling agent.
Patients receive Cetuximab-IRDye 800CW intravenously (IV) at 50 mg or 100 mg over 30 minutes to 1 hour on day 0. Within 2 to 5 days, patients undergo surgery with intraoperative imaging. Cetuximab-IRDye 800CW is used as part of a tumor-targeted molecular imaging procedure operating on the principles of differential accumulation of the antibody-dye conjugate in pancreatic tumor tissue vs normal pancreatic tissue vs pancreatitis tissue.
Excised tissues are prepared as formalin-fixed paraffin-embedded (FFPE) blocks for assessment of fluorescent intensity.
Photoacoustic imaging (PAI) For purposes of non-quantitative comparison, photoacoustic imaging (PAI) of the tumor lesions is also conducted. PAI refers to a non-invasive evaluation by ultrasound of the area of the resected tumor and surrounding tissue. PAI may have special utility for detecting tumors within 5 to 7 mm of depth, with a high degree of spatial resolution, which might be useful to enhance generation of tumor-free surgical margins. PAI does not utilize ionizing radiation, and should complement and conform to the findings from the fluorescent imaging.
PRIMARY OBJECTIVE:
Determine the efficacy of cetuximab-IRDye800 in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.
SECONDARY OBJECTIVE:
Determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab IRDye800, 50 mg | Experimental | Drug: Cetuximab-IRDye800, Drug: CetuximabOn 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, 100 mg | Experimental | Drug: Cetuximab-IRDye800, Drug: CetuximabOn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
- Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
- ≥ 19 years of age
- Life expectancy of more than 12 weeks
- EITHER
Key exclusion criteria (7 listed)
- Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
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 |
|---|---|---|
| Cetuximab-IRDye800Also: Cetuximab-IRDye 800CWAdministered intravenously (IV) at 50 or 100 mg | Drug | Cetuximab IRDye800, 100 mg, Cetuximab IRDye800, 50 mg |
| CetuximabAlso: Erbitux, C225Administered as a 100 mg IV loading dose | Drug | Cetuximab IRDye800, 100 mg, Cetuximab IRDye800, 50 mg |
Primary outcome
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses
Time frame: up to 5 days
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.
7 secondary outcomes
Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo)
Time frame: up to 14 days
Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity
Time frame: up to 14 days
Sensitivity and Specificity of Ex Vivo Fluorescent Imaging
Time frame: up to 14 days
Cetuximab-IRDye800 Tumor Detection in Lymph Nodes
Time frame: up to 14 days
Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI)
Time frame: up to 5 days
Signal-to-Noise Ratio (SNR) by In Vivo Photoacoustic Imaging (PAI)
Time frame: up to 5 days
Toxicity (≥ Grade 2)
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17431103Rosenthal EL, Kulbersh BD, King T, Chaudhuri TR, Zinn KR. Use of fluorescent labeled anti-epidermal growth factor receptor antibody to image head and neck squamous cell carcinoma xenografts. Mol Cancer Ther. 2007 Apr;6(4):1230-8. doi: 10.1158/1535-7163.MCT-06-0741.
- Background: PubMed 16954995Rosenthal EL, Kulbersh BD, Duncan RD, Zhang W, Magnuson JS, Carroll WR, Zinn K. In vivo detection of head and neck cancer orthotopic xenografts by immunofluorescence. Laryngoscope. 2006 Sep;116(9):1636-41. doi: 10.1097/01.mlg.0000232513.19873.da.
- Results publication: PubMed 29667116Tummers WS, Miller SE, Teraphongphom NT, Gomez A, Steinberg I, Huland DM, Hong S, Kothapalli SR, Hasan A, Ertsey R, Bonsing BA, Vahrmeijer AL, Swijnenburg RJ, Longacre TA, Fisher GA, Gambhir SS, Poultsides GA, Rosenthal EL. Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging. Ann Surg Oncol. 2018 Jul;25(7):1880-1888. doi: 10.1245/s10434-018-6453-2. Epub 2018 Apr 17.
- Derived from this study: PubMed 32416765Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available.
- 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.
George Poultsides, MD principal investigator
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 2 study testing Cetuximab-IRDye800 and Cetuximab in people with Pancreatic Adenocarcinoma, run by Eben Rosenthal 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Jun 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Feb 2019). 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?
Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses (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?
On the ClinicalTrials.gov record for NCT02736578, which also lists 4 linked publications.
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 25 Jun 2019.