- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470259
Precision Thyroid Cancer Surgery With Molecular Fluorescent Guided Imaging (TARGET)
Detection of Thyroid Cancer and Central Lymph Node Metastases Using EMI-137 Enhanced Molecular Fluorescent Guided Imaging: a Multicentre Feasibility and
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9713GZ
- University Medical Center Groningen
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Rotterdam, Netherlands
- Erasmus Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years, eligible for surgery
- Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC metastasis (primary or recurrence).
- Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.
- WHO performance score of 0-2.
- Written informed consent.
- Mentally competent person who is able and willing to comply with study procedures.
For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal:
- A negative serum pregnancy test prior to receiving the tracer
- Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Exclusion Criteria:
- Pregnancy or breast feeding
- Advanced stage thyroid cancer not suitable for surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
- The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months
- History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment
- Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EMI-137 0.09mg/kg administration
Three patients will be once administered with EMI-137 0.09 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision.
Thereafter will be an observational period of an hour.
Other Names:
A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
Other Names:
A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
|
Experimental: EMI-137 0.13mg/kg administration
Three patients will be once administered with EMI-137 0.13 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision.
Thereafter will be an observational period of an hour.
Other Names:
A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
Other Names:
A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
|
Experimental: EMI-137 0.18mg/kg administration
Three patients will be once administered with EMI-137 0.18 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision.
Thereafter will be an observational period of an hour.
Other Names:
A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
Other Names:
A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
|
Experimental: EMI-137 0.045mg/kg administration
If we have a excellent tumor to background ratio ((tumor fluorescence)/(surrounding tissue fluorescence)) in the 0.09 mg/kg group, we will de-escalate back to a 0.045 mg/kg group to evaluate TBR and reduce possible tracer toxicity in a thyroid cancer population with 90% 20 year survival. Three patients will be once administered with EMI-137 0.045 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision.
Thereafter will be an observational period of an hour.
Other Names:
A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
Other Names:
A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The feasibility of Molecular Fluorescence Guided Surgery using EMI-137
Time Frame: From tracer administration until after data analyses which will take up to 1.5year
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To determine the optimal dose of the c-Met targeting NIRF tracer EMI-137 for an adequate TBR in PTC lymph nodes metastases using 3, and possibly 4, different dosages op EMI-137.
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From tracer administration until after data analyses which will take up to 1.5year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of using EMI-137 through monitoring vital signs
Time Frame: 1 day
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To evaluate the safety of EMI-137 through monitoring vital signs for evaluating possible (severe) adverse events.
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1 day
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Safety of using EMI-137 through monitoring injection site
Time Frame: 1 day
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To evaluate the safety of EMI-137 through monitoring the injection site for evaluating possible (severe) adverse events.
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1 day
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Feasibility of MFGS for detecting nodal metastasis
Time Frame: Up to one year
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To evaluate the feasibility of MFGS for the assessment of PTC and nodal metastasis by calculating target-to-background ratio.
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Up to one year
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Feasibility of spectroscopy for detecting fluorescence of PTC and lymph nodes
Time Frame: Up to one year
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To determine the feasibility of ex vivo spectroscopy measurements of PTC and lymph nodes for quantification of the fluorescence signal of EMI-137
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Up to one year
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Validation of flourescence
Time Frame: Up to one year
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To correlate and validate fluorescence signals detected ex vivo with histopathology and immunohistochemistry by determining if high flourescence areas show tumorcells in pathological examination.
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Up to one year
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Distribution of EMI-137
Time Frame: Up to 1.5 year
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To evaluate the distribution of EMI-137 on a microscopic level using fluorescence microscopy.
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Up to 1.5 year
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Sensitivity and specificity of EMI-137
Time Frame: Up to 1.5 year
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To quantify sensitivity and specificity of EMI-137 for PTC and nodal metastasis in order to make a power size calculation for a possible subsequent diagnostic accuracy study.
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Up to 1.5 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Schelto Kruijfff, MD, PhD, University Medical Center Groningen
- Principal Investigator: Gooitzen M van Dam, MD, PhD, University Medical Center Groningen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplastic Processes
- Adenocarcinoma, Papillary
- Neoplasm Metastasis
- Thyroid Diseases
- Lymphatic Metastasis
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
Other Study ID Numbers
- NL62817.042.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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