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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Completed; Phase 1

Conditions: Solid Tumor, Adult

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05620472

[99mTc]Tc(CO)3-(HE)3-Ec1

Details and patient eligibility

About

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.

Full 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:

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

Enrollment: 10 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 3 patient groups

[99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg

Experimental group

Description:

At least five (5) evaluable subjects with solid tumor.

Treatment:

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

[99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg

Experimental group

Description:

At least five (5) evaluable subjects with solid tumor.

Treatment:

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

[99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg

Experimental group

Description:

At least five (5) evaluable subjects with solid tumor.

Treatment:

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