Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1
NCT ID: NCT06386653
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2024-04-14
2024-12-31
Brief Summary
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The primary objective are:
1. To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of \[123I\]I-DARPIN-Ec1.
3. To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage.
The secondary objective are:
1\. To compare the obtained \[123I\]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients.
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Detailed Description
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Phase I of the study:
Biodistribution of \[123I\]I-DARPIN-Ec1 in patients with lung and ovarian cancer .
The main objectives of the study:
1. To evaluate the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors in patients with lung and ovarian cancer at different time intervals.
2. To evaluate dosimetry of \[123I\]I-DARPIN-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 \[123I\]I-DARPIN-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 lung and ovarian cancer by SPECT using \[123I\]I-DARPIN-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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
At least five (5) evaluable subjects with lung cancer.
Diagnostic injection of [123I]I-DARPIN-Ec1
A single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body SPECT with [123I]I-DARPIN-Ec1
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
At least five (5) evaluable subjects with ovarian cancer.
Diagnostic injection of [123I]I-DARPIN-Ec1
A single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body SPECT with [123I]I-DARPIN-Ec1
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Interventions
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Diagnostic injection of [123I]I-DARPIN-Ec1
A single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Whole-body SPECT with [123I]I-DARPIN-Ec1
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of \[123I\]I-DARPIN-Ec1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical and radiological diagnosis of lung and ovarian cancer 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
* Subject is \> 18 years of age
* Clinical and radiological diagnosis of lung and ovarian cancer 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 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
18 Years
70 Years
ALL
No
Sponsors
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Uppsala University
OTHER
The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry
UNKNOWN
Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Vladimir I Chernov, MD, Prof
Role: STUDY_DIRECTOR
Oncology Research Institute of Tomsk NRMC
Locations
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TomskNRMC
Tomsk, , Russia
Countries
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Other Identifiers
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[123I]I-DARPIN-Ec1
Identifier Type: -
Identifier Source: org_study_id
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