Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic injection of [123I]I-DARPIN-Ec1 | Drug | — | UNRESOLVED |
| Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 | Diagnostic Test | — | UNRESOLVED |
| Whole-body SPECT with [123I]I-DARPIN-Ec1 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
- description
- At least five (5) evaluable subjects with lung cancer.
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
- description
- At least five (5) evaluable subjects with ovarian cancer.
- interventionNames
- 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
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available