Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

Tomsk National Research Medical Center of the Russian Academy of Sciences10 enrolled

Overview

The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The primary objective are: 1. To assess the distribution of \[99mTc\]Tc- DB8 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc- DB8. 3. To study the safety and tolerability of the drug \[99mTc\]Tc- DB8 after a single injection in a diagnostic dosage. The secondary objective are: 1\. To compare the obtained \[99mTc\]Tc- DB8 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and breast cancer patients.

The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled DB8. Phase I of the study: Biodistribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The main objectives of the study: 1. To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. 2. To evaluate dosimetry of 99mTc-DB8 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 99mTc-DB8 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 prostate cancer and breast cancer by SPECT using 99mTc-DB8 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is \> 18 years of age * Clinical and radiological diagnosis of prostate cancer and breast 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

Outcomes

Primary Outcomes

Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)

Whole-body \[99mTc\]Tc-DB8 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

Time frame: 24 hours

SPECT-based [99mTc]Tc-DB8 value in tumor lesions (counts)

\[99mTc\]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

Time frame: 6 hours

SPECT-based [99mTc]Tc-DB8 background uptake value (counts)

Focal uptake of \[99mTc\]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts

Time frame: 6 hours

Tumor-to-background ratio (SPECT)

The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (counts)

Time frame: 6 hours

Secondary Outcomes

Safety attributable to [99mTc]Tc-DB8 injections (physical findings)

The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline).

Time frame: 24 hours

Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)

The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline).

Time frame: 24 hors

Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)

The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).

Time frame: 24 hours

Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)

The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).

Time frame: 24 hours

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes