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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940298
• Other study ID #: [99mTc]Tc- DB8
• Status: Recruiting
• Phase: Phase 1
• Start date: July 3, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Vladimir I Chernov, MD,Prof
• Phone: +73822426284
• Email: chernov[@]tnimc.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Intravenous injection of [99mTc]Tc-DB8
One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Locations

Country	Name	City	State
Russian Federation	TomskNRMC	Tomsk

Sponsors (2)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences	Uppsala University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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