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AzTrials

Lung CancerPhase 1NCT06386653

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

A Phase 1 study testing Diagnostic injection of [123I]I-DARPIN-Ec1, Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 and Whole-body SPECT with [123I]I-DARPIN-Ec1 in people with Lung Cancer and Ovarian Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Cancer, Ovarian Cancer
What is being tested?
Diagnostic injection of [123I]I-DARPIN-Ec1, Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 and Whole-body SPECT with [123I]I-DARPIN-Ec1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteRussia
Study dates
14 Apr 2024to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • TomskNRMC

    Tomsk

Other trials in Russia

About this study

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

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.
Read the 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.

Being tested
Diagnostic injection of [123I]I-DARPIN-Ec1, Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1, Whole-body SPECT with [123I]I-DARPIN-Ec1
Keywords
Lung cancer, Оvarian cancer, [123I]I-DARPIN-Ec1, SPECT
Medical subject headings
Lung Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic injection of [123I]I-DARPIN-Ec1Drug

    Also called [123I]I-DARPIN-Ec1 injection

    A single intravenous injection of [123I]I-DARPIN-Ec1

  • Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1Diagnostic test

    Also called [123I]I-DARPIN-Ec1 scintigraphy

    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-Ec1Diagnostic test

    Also called [123I]I-DARPIN-Ec1 SPECT

    Whole-body SPECT at 2, 4, and 6 hours after a single intravenous injection of [123I]I-DARPIN-Ec1

Study groups in NCT06386653
Study groupRoleWhat they receive
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancerExperimentalAt least five (5) evaluable subjects with lung cancer.
Receives: Drug: Diagnostic injection of [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body SPECT with [123I]I-DARPIN-Ec1
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancerExperimentalAt least five (5) evaluable subjects with ovarian cancer.
Receives: Drug: Diagnostic injection of [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1; Diagnostic Test: Whole-body SPECT with [123I]I-DARPIN-Ec1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

  2. 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

    Measured: 6 hours

  3. 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

    Measured: 6 hours

  4. 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)

    Measured: 6 hours

Secondary outcomes (4)

  1. 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).

    Measured: 24 hours

  2. 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)

    Measured: 24 hours

  3. 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)

    Measured: 24 hours

  4. 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)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start14 Apr 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386653
Sponsor's protocol ID
ORI-18/2
Status last verified
Jun 2026
First submitted
23 Apr 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD may be shared on request after consideration of requester's application.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Diagnostic injection of [123I]I-DARPIN-Ec1, Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 and Whole-body SPECT with [123I]I-DARPIN-Ec1 in people with Lung Cancer and Ovarian Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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