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

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

NCT ID: NCT05620472

Condition: Solid Tumor, Adult

Conditions: Keywords:
Solid tumor
EpCAM receptors
[99mTc]Tc(CO)3-(HE)3-Ec1
SPECT

Study type: Interventional

Study phase: Phase 1

Overall status: Enrolling by invitation

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1
Description: One single intravenous injection of [99mTc]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Arm group label: [99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg
Arm group label: [99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg
Arm group label: [99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg

Other name: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT

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.

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: 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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: TomskNRMC

Address:
City: Tomsk
Country: Russian Federation

Start date: October 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Tomsk National Research Medical Center of the Russian Academy of Sciences
Agency class: Other

Collaborator:
Agency: Uppsala University
Agency class: Other

Source: Tomsk National Research Medical Center of the Russian Academy of Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05620472