Clinical trial NCT05620472: Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1
Official title: SPECT Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1 in Solid Tumors Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: Solid tumor
EpCAM receptors
[99mTc]Tc(CO)3-(HE)3-Ec1
SPECT
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2022-11-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Gamma camera-based whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (%)
timeFrame: 24 hours
measure: SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts)
timeFrame: 6 hours
measure: SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (counts)
timeFrame: 6 hours
measure: Tumor-to-background ratio (SPECT)
timeFrame: 6 hours
Secondary outcomes:
measure: Percent of cases with abnormal findings in physical examination, vital signs, and ECG associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections
timeFrame: 24 hours
measure: Percent of cases with abnormal laboratory test results associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections
timeFrame: 24 hours
measure: Incidence and severity of adverse events associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections
timeFrame: 24 hours
measure: Percent of cases requiring administration of concomitant medication due to [99mTc]Tc(CO)3-(HE)3-Ec1 injections
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: Cardiology Research Institute, Tomsk National Research Medic
name: Vladimir I Chernov, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: