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

Study Overview
=================
Brief Summary
-----------------
The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The primary objective are: To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals. To evaluate dosimetry of [99mTc]Tc- DB8. 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: To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. To evaluate dosimetry of 99mTc-DB8 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 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.

Official Title
-----------------
SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients

Conditions
-----------------
Prostate Cancer, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Intravenous injection of [99mTc]Tc-DB8


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer<br>At least five (5) evaluable subjects with prostate cancer | Drug: Intravenous injection of [99mTc]Tc-DB8<br>* One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: [99mTc]Tc-DB8;|
| Experimental: Breast cancer<br>At least five (5) evaluable subjects with breast cancer | Drug: Intravenous injection of [99mTc]Tc-DB8<br>* One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: [99mTc]Tc-DB8;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Breast cancer, Gastrin releasing peptide receptors, [99mTc]Tc-DB8, SPECT