Clinical trial · Interventional
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole body study and SPECT with [99mTc]Tc-BQ0413 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Prostate cancer 50 mkg
- description
- At least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (50 mkg)
- interventionNames
- Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413
- type
- EXPERIMENTAL
- label
- Experimental: Prostate cancer 100 mkg
- description
- At leaAt least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (100 mkg)
- interventionNames
- Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413
Primary outcomes (4)
- measure
- Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
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