- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06386653
Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1
SPECT Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 in Lung and Ovarian Cancers Patients
The study should evaluate the biological distribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer
The primary objective are:
- To assess the distribution of [123I]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [123I]I-DARPIN-Ec1.
- 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.
Study Overview
Status
Conditions
Detailed Description
The overall goal is to study the effectiveness of SPECT imaging lung and ovarian cancer using [123I]I-DARPIN-Ec1.
Phase I of the study:
Biodistribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer .
The main objectives of the study:
- 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.
- To evaluate dosimetry of [123I]I-DARPIN-Ec1 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Tomsk, Russian Federation
- TomskNRMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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:
Inclusion Criteria:
- 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
At least five (5) evaluable subjects with lung cancer.
|
A single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
|
Experimental: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
At least five (5) evaluable subjects with ovarian cancer.
|
A single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)
Time Frame: 24 hours
|
Whole-body [123I]I-DARPIN-Ec1 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
|
24 hours
|
SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)
Time Frame: 6 hours
|
[123I]I-DARPIN-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
|
6 hours
|
SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)
Time Frame: 6 hours
|
Focal uptake of [123I]I-DARPIN-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts
|
6 hours
|
Tumor-to-background ratio (SPECT)
Time Frame: 6 hours
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The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [123I]I-DARPIN-Ec1 uptake coinciding with tumor lesions (counts) will be divided by the value of [123I]I-DARPIN-Ec1 uptake coinciding with the regions without pathological findings (counts)
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6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.
Time Frame: 24 hours
|
The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the assessments of physical examination, vital signs and ECG (percent of cases with abnormal findings relative to baseline).
|
24 hours
|
Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.
Time Frame: 24 hours
|
The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
|
24 hours
|
Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections
Time Frame: 24 hours
|
The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the rate of adverse events (percent)
|
24 hours
|
Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections
Time Frame: 24 hours
|
The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the rate of administration of concomitant medication (percent)
|
24 hours
|
Collaborators and Investigators
Investigators
- Study Director: Vladimir I Chernov, MD, Prof, Oncology Research Institute of Tomsk NRMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- [123I]I-DARPIN-Ec1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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