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Trial Title:
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
NCT ID:
NCT06101927
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate-Specific Membrane Antigen
Prostate cancer
[99mTc]Tc-BQ0413
SPECT
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Whole body study and SPECT with [99mTc]Tc-BQ0413
Description:
One single intravenous injection of [99mTc]Tc-BQ0413, followed by gamma camera imaging
after 2, 4, 6 and 24 hours.
Arm group label:
Experimental: Prostate cancer 100 mkg
Arm group label:
Experimental: Prostate cancer 50 mkg
Other name:
Diagnostic Test:
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 normal tissues and tumors at
different time intervals.
2. To evaluate dosimetry of [99mTc]Tc- BQ0413.
3. To study the safety and tolerability of the drug [99mTc]Tc- BQ0413 after a single
injection in a diagnostic dosage.
The secondary objective are:
1. To compare the obtained [99mTc]Tc- BQ0413 SPECT imaging results with the data of CT
and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in
prostate cancer patients.
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 with prostate cancer.
The main objectives of the study:
1. To evaluate the distribution of [99mTc]Tc-BQ0413 in normal tissues and tumors in
patients with prostate cancer at different time intervals.
2. To evaluate dosimetry of [99mTc]Tc-BQ0413 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]Tc-BQ0413 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 by SPECT using [99mTc]Tc-BQ0413 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 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
Gender:
Male
Gender based:
Yes
Gender description:
Men
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
TomskNRMC
Address:
City:
Tomsk
Country:
Russian Federation
Start date:
October 19, 2023
Completion date:
October 30, 2024
Lead sponsor:
Agency:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Agency class:
Other
Collaborator:
Agency:
Uppsala University
Agency class:
Other
Source:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06101927
