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Completed
NCT05620472
Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1
Conditions: Solid Tumor, Adult
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Location: TomskNRMC Tomsk
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:
1. To assess the distribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of \[99mTc\]Tc(CO)3-(HE)3-Ec1 .
3. 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05620472). StuddyBuddy aggregates publicly available trial information.