Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05940298
Study type	Interventional
Source	Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact	Vladimir I Chernov, MD,Prof
Phone	+73822426284
Email	chernov@tnimc.ru
Status	Recruiting
Phase	Phase 1
Start date	July 3, 2023
Completion date	July 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04681911` - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer	Phase 2
Completed	`NCT04890327` - Web-based Family History Tool	N/A
Terminated	`NCT04066790` - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	Phase 2
Completed	`NCT03591848` - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility	N/A
Recruiting	`NCT03954197` - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	N/A
Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Active, not recruiting	`NCT01472094` - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn	`NCT06057636` - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study	N/A
Completed	`NCT06049446` - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting	`NCT05560334` - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations	Phase 2
Active, not recruiting	`NCT05501769` - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer	Phase 1
Recruiting	`NCT04631835` - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer	Phase 1
Completed	`NCT04307407` - Exercise in Breast Cancer Survivors	N/A
Recruiting	`NCT03544762` - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation	Phase 3
Terminated	`NCT02482389` - Study of Preoperative Boost Radiotherapy	N/A
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Completed	`NCT00226967` - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms