SPECT Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 in Lung and Ovarian Cancers Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)
Study Overview
Brief Summary
The study should evaluate the biological distribution of [123I]I-DARPIN-Ec1 in patients with lung and ovarian cancer
The primary objective are:
- To assess the distribution of [123I]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [123I]I-DARPIN-Ec1.
- 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.
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:
- 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.
- To evaluate dosimetry of [123I]I-DARPIN-Ec1 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- To study the safety of use and tolerability of the drug [123I]I-DARPIN-Ec1 after a single intravenous administration in a diagnostic dosage.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
At least five (5) evaluable subjects with lung cancer.
Intervention: Diagnostic injection of [123I]I-DARPIN-Ec1 (Drug)
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
At least five (5) evaluable subjects with lung cancer.
Intervention: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 (Diagnostic Test)
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in lung cancer
At least five (5) evaluable subjects with lung cancer.
Intervention: Whole-body SPECT with [123I]I-DARPIN-Ec1 (Diagnostic Test)
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
At least five (5) evaluable subjects with ovarian cancer.
Intervention: Diagnostic injection of [123I]I-DARPIN-Ec1 (Drug)
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
At least five (5) evaluable subjects with ovarian cancer.
Intervention: Whole-body planar scintigraphy with [123I]I-DARPIN-Ec1 (Diagnostic Test)
Whole-body planar scintigraphy and SPECT with [123I]I-DARPIN-Ec1 in ovarian cancer
At least five (5) evaluable subjects with ovarian cancer.
Intervention: Whole-body SPECT with [123I]I-DARPIN-Ec1 (Diagnostic Test)
Outcomes
Primary Outcomes
SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts)
Time Frame: 6 hours
\[123I\]I-DARPIN-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts)
Time Frame: 6 hours
Focal uptake of \[123I\]I-DARPIN-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts
Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%)
Time Frame: 24 hours
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
Tumor-to-background ratio (SPECT)
Time Frame: 6 hours
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)
Secondary Outcomes
- Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections.(24 hours)
- Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections(24 hours)
- Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections(24 hours)
- Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections.(24 hours)