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

Lung Cancer Clinical Trial

Official title:

SPECT Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 in Lung and Ovarian Cancers Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06386653
• Other study ID #: [123I]I-DARPIN-Ec1
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: April 14, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Diagnostic injection of [123I]I-DARPIN-Ec1
A single intravenous injection of [123I]I-DARPIN-Ec1

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Russian Federation	TomskNRMC	Tomsk

Sponsors (3)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences	The Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry, Uppsala University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)	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
Primary	SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)	[123I]I-DARPIN-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts	6 hours
Primary	SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)	Focal uptake of [123I]I-DARPIN-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts	6 hours
Primary	Tumor-to-background ratio (SPECT)	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)	6 hours
Secondary	Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.	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
Secondary	Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.	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
Secondary	Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections	The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the rate of adverse events (percent)	24 hours
Secondary	Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections	The safety attributable to [123I]I-DARPIN-Ec1 injections will be evaluated based on the rate of administration of concomitant medication (percent)	24 hours