A Phase 1 interventional study of Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1 in Solid Tumor, Adult, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Completed at 1 site in Russia. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Phase 1, Interventional, and Diagnostic
The study should evaluate the biological distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor
The primary objective are:
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.
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:
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.
Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6 hours
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 hours
Plan to share: Yes — IPD may be shared on request after consideration of requester's application.
Supporting information: Study protocol, Sap
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tomsk National Research Medical Center of the Russian Academy of Sciences