CompletedPhase 1

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

Russia10 participantsStarted 2024-04-14

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)

Timeframe: 24 hours

SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)

Timeframe: 6 hours

SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)

Timeframe: 6 hours

Tumor-to-background ratio (SPECT)

Timeframe: 6 hours

Trial details

NCT IDNCT06386653

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.