Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8
- Conditions
- Prostate CancerBreast Cancer
- Interventions
- Drug: Intravenous injection of [99mTc]Tc-DB8
- Registration Number
- NCT05940298
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prostate cancer Intravenous injection of [99mTc]Tc-DB8 At least five (5) evaluable subjects with prostate cancer Breast cancer Intravenous injection of [99mTc]Tc-DB8 At least five (5) evaluable subjects with breast cancer
- Primary Outcome Measures
Name Time Method Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%) 24 hours 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
SPECT-based [99mTc]Tc-DB8 value in tumor lesions (counts) 6 hours \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-DB8 background uptake value (counts) 6 hours Focal uptake of \[99mTc\]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT) 6 hours 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)
- Secondary Outcome Measures
Name Time Method Safety attributable to [99mTc]Tc-DB8 injections (physical findings) 24 hours 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).
Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests) 24 hors 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).
Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication) 24 hours The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).
Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events) 24 hours The safety attributable to \[99mTc\]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).
Trial Locations
- Locations (1)
TomskNRMC
🇷🇺Tomsk, Russian Federation