Fact CheckerSign in

NCT06386653CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (actual)
First submitted
23 Apr 2024
Start date
14 Apr 2024
Primary completion date
31 Dec 2024
Lead sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
NCT number
NCT06386653

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 10
  • From 14 Apr 2024 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
  • Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Other illness

  • Active current autoimmune disease or history of autoimmune disease
  • Known HIV positive or chronically active hepatitis B or C

Other

  • Administration of other investigational medicinal product within 30 days of screening

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
TomskNRMC
Coordinator of this site? Confirm its status		TomskRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.