Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1

Study Overview
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Brief Summary
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The study should evaluate the biological distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor The primary objective are: To assess the distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals. To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 . 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: 1. 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.

Detailed Description
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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: 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. To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 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: 1. 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.

Official Title
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SPECT Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1 in Solid Tumors Patients

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years of age Clinical and radiological diagnosis of solid tumor with histological verification. White blood cell count: > 2.0 x 10^9/L Haemoglobin: > 80 g/L Platelets: > 50.0 x 10^9/L Bilirubin =< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits Blood glucose level not more than 5.9 mmol/L 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 Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: Active current autoimmune disease or history of autoimmune disease Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) Known HIV positive or chronically active hepatitis B or C Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg<br>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<br>* One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT;|
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg<br>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<br>* One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT;|
| Experimental: [99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg<br>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<br>* One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma camera-based whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (%) | 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 | 24 hours | 
| SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts) | [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 | 6 hours | 
| SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (counts) | 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 | 6 hours | 
| Tumor-to-background ratio (SPECT) | 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) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of cases with abnormal findings in physical examination, vital signs, and ECG associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections | 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) | 24 hours | 
| Percent of cases with abnormal laboratory test results associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections | 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) | 24 hours | 
| Incidence and severity of adverse events associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections | The safety attributable to [99mTc]Tc(CO)3-(HE)3-Ec1 injections will be evaluated based on the rate of adverse events (percent) | 24 hours | 
| Percent of cases requiring administration of concomitant medication due to [99mTc]Tc(CO)3-(HE)3-Ec1 injections | 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) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumor, EpCAM receptors, [99mTc]Tc(CO)3-(HE)3-Ec1, SPECT