Status:

COMPLETED

Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413

Lead Sponsor:

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborating Sponsors:

Uppsala University

Conditions:

Prostate Cancer

Eligibility:

MALE

18-75 years

Phase:

PHASE1

Brief Summary

The study should evaluate the biological distribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer. The primary objective are: 1. To assess the distribution of \[99mTc\]Tc- BQ0413 in norma...

Detailed Description

The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413. Phase I of the study: Biodistribution of \[99mTc\]Tc-BQ0413 in patients ...

Eligibility Criteria

Inclusion

  • Subject is \> 18 years of age
  • Clinical and radiological diagnosis of prostate 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
  • Subject is capable to undergo the diagnostic investigations to be performed in the study
  • Informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

October 19 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2024

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT06101927

Start Date

October 19 2023

End Date

December 30 2024

Last Update

April 9 2025

Active Locations (1)

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1

TomskNRMC

Tomsk, Russia