Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Gastrointestinal Agents

Gastrins

Bombesin

Gastrin-Releasing Peptide

At least five (5) evaluable subjects with prostate cancer

At least five (5) evaluable subjects with breast cancer

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

Intravenous injection of [99mTc]Tc-DB8

Vladimir I Chernov, MD,Prof

Anastasiy N Rybina, MD,PhD

Vladimir I Chernov, MD, Prof.

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.

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

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

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

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

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

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)

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).

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).

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

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

Uppsala University

Tomsk National Research Medical Center of the Russian Academy of Sciences

At least five (5) evaluable subjects with prostate cancer.

At least five (5) evaluable subjects breast cancer.

One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

whole body study and SPECT with 99mTc-RM26

Vladimir I Chernov, MD,PhD

The study should evaluate the biological distribution of 99mTc-RM26 in patients with prostate cancer and breast cancer.

The primary objective are:

1. To assess the distribution of 99mTc- RM26 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of 99mTc- RM26.
3. To study the safety and tolerability of the drug 99mTc- RM26 after a single injection in a diagnostic dosage.

The secondary objective are:

1. To compare the obtained 99mTc- RM26 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 RM26.

Phase I of the study:

Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer.

The main objectives of the study:

1. To evaluate the distribution of 99mTc-RM26 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals.
2. To evaluate dosimetry of 99mTc-RM26 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-RM26 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-RM26 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.

Men for prostate cancer and women for breast cancer

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26

SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26 (99mTc- RM26) in Prostate Cancer and Breast Cancer Patients

Whole-body 99mTc-RM26 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

99mTc-RM26 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

Focal uptake of 99mTc-RM26 in the regions without pathological findings will be assessed with SPECT and measured in counts

The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-RM26 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-RM26 uptake coinciding with the regions without pathological findings (counts)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of adverse events (percent)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of administration of concomitant medication (percent)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8	NCT05940298	Prostate Cancer Breast Cancer	Intravenous inj...	18 Years - 75 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26	NCT04746638	Prostate Cancer Breast Cancer F...	whole body stud...	18 Years - 70 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26	NCT04746638	Prostate Cancer Breast Cancer F...	whole body stud...	18 Years - 70 Years	Tomsk National Research Medical Center of the Russian Academy of Sciences

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