Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386653
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
Molecular Imaging of EpCAM Receptors Using 123II-DARPIN-Ec1
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Overview
Official Title:
SPECT Imaging of EpCAM Receptors Using 123II-DARPIN-Ec1 in Lung and Ovarian Cancers Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study should evaluate the biological distribution of 123II-DARPIN-Ec1 in patients with lung and ovarian cancer
The primary objective are
1 To assess the distribution of 123II-DARPIN-Ec1 in normal tissues and tumors at different time intervals
2 To evaluate dosimetry of 123II-DARPIN-Ec1
3 To study the safety and tolerability of the drug 123II-DARPIN-Ec1 after a single injection in a diagnostic dosage
The secondary objective are
1 To compare the obtained 123II-DARPIN-Ec1 SPECT imaging results with the data of CT andor MRI andor ultrasound examination and immunohistochemical IHC studies in lung and ovarian cancer patients
The primary objective are
1 To assess the distribution of 123II-DARPIN-Ec1 in normal tissues and tumors at different time intervals
2 To evaluate dosimetry of 123II-DARPIN-Ec1
3 To study the safety and tolerability of the drug 123II-DARPIN-Ec1 after a single injection in a diagnostic dosage
The secondary objective are
1 To compare the obtained 123II-DARPIN-Ec1 SPECT imaging results with the data of CT andor MRI andor 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 123II-DARPIN-Ec1
Phase I of the study
Biodistribution of 123II-DARPIN-Ec1 in patients with lung and ovarian cancer
The main objectives of the study
1 To evaluate the distribution of 123II-DARPIN-Ec1 in normal tissues and tumors in patients with lung and ovarian cancer at different time intervals
2 To evaluate dosimetry of 123II-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 123II-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 123II-DARPIN-Ec1 with data obtained by CT andor MRI andor 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
Phase I of the study
Biodistribution of 123II-DARPIN-Ec1 in patients with lung and ovarian cancer
The main objectives of the study
1 To evaluate the distribution of 123II-DARPIN-Ec1 in normal tissues and tumors in patients with lung and ovarian cancer at different time intervals
2 To evaluate dosimetry of 123II-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 123II-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 123II-DARPIN-Ec1 with data obtained by CT andor MRI andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None