Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1

Trial Title: Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1

NCT ID: NCT06386653

Condition: Lung Cancer
Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Conditions: Keywords:
Lung cancer
Оvarian cancer
[123I]I-DARPIN-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 injection of [123I]I-DARPIN-Ec1
Description: A single intravenous injection of [123I]I-DARPIN-Ec1
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

Other name: [123I]I-DARPIN-Ec1 injection

Intervention type: Diagnostic Test
Intervention name: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1
Description: Gamma camera-based whole-body planar scintigraphy imaging 2, 4, 6, and 24 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

Other name: [123I]I-DARPIN-Ec1 scintigraphy

Intervention type: Diagnostic Test
Intervention name: Whole-body SPECT with [123I]I-DARPIN-Ec1
Description: Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of [123I]I-DARPIN-Ec1
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
Arm group label: Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer

Other name: [123I]I-DARPIN-Ec1 SPECT

Summary: The study should evaluate the biological distribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer 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.

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: 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.

Criteria for eligibility:
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: 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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: TomskNRMC

Address:
City: Tomsk
Country: Russian Federation

Start date: April 14, 2024

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

Collaborator:
Agency: The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry
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/NCT06386653