Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1
Study Details
Study Description
Brief Summary
The study should evaluate the biological distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor
The primary objective are:
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To assess the distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals.
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To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 .
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To study the safety and tolerability of the drug [99mTc]Tc(CO)3-(HE)3-Ec1 after a single injection in a diagnostic dosage.
The secondary objective are:
- To compare the obtained [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in solid tumor patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The overall goal is to study the effectiveness of SPECT imaging solid tumor patients using [99mTc]Tc(CO)3-(HE)3-Ec1.
Phase I of the study:
Biodistribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor.
The main objectives of the study:
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To evaluate the distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors in patients with solid tumor at different time intervals.
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To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
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To study the safety of use and tolerability of the drug [99mTc]Tc(CO)3-(HE)3-Ec1 after a single intravenous administration in a diagnostic dosage.
Additional research tasks:
- To conduct a comparative analysis of the diagnostic information obtained in the visualization of solid tumor by SPECT using [99mTc]Tc(CO)3-(HE)3-Ec1 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg At least five (5) evaluable subjects with solid tumor. |
Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1
One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Other Names:
|
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg At least five (5) evaluable subjects with solid tumor. |
Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1
One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Other Names:
|
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg At least five (5) evaluable subjects with solid tumor. |
Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1
One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Gamma camera-based whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (%) [24 hours]
Whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
- SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts) [6 hours]
[99mTc]Tc(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
- SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (counts) [6 hours]
Focal uptake of [99mTc]Tc(CO)3-(HE)3-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts
- Tumor-to-background ratio (SPECT) [6 hours]
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc(CO)3-(HE)3-Ec1 uptake coinciding with the regions without pathological findings (counts)
Secondary Outcome Measures
- Percent of cases with abnormal findings in physical examination, vital signs, and ECG associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections [24 hours]
The safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)
- Percent of cases with abnormal laboratory test results associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections [24 hours]
Safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections (laboratory tests) The safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
- Incidence and severity of adverse events associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections [24 hours]
The safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections will be evaluated based on the rate of adverse events (percent)
- Percent of cases requiring administration of concomitant medication due to [99mTc]Tc(CO)3-(HE)3-Ec1 injections [24 hours]
The safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections will be evaluated based on the rate of administration of concomitant medication (percent)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is > 18 years of age
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Clinical and radiological diagnosis of solid tumor with histological verification.
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White blood cell count: > 2.0 x 10^9/L
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Haemoglobin: > 80 g/L
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Platelets: > 50.0 x 10^9/L
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Bilirubin =< 2.0 times Upper Limit of Normal
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Serum creatinine: Within Normal Limits
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Blood glucose level not more than 5.9 mmol/L
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A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
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Subject is capable to undergo the diagnostic investigations to be performed in the study
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Informed consent
Exclusion Criteria:
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Active current autoimmune disease or history of autoimmune disease
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Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
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Known HIV positive or chronically active hepatitis B or C
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Administration of other investigational medicinal product within 30 days of screening
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Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TomskNRMC | Tomsk | Russian Federation |
Sponsors and Collaborators
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Uppsala University
Investigators
- Principal Investigator: Vladimir I Chernov, MD, Prof, Cardiology Research Institute, Tomsk National Research Medic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- [99mTc]Tc(CO)3-(HE)3-Ec1