Clinical trial · Interventional
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
NCT03039413CI-TRIAL-00094037completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Copper Cu 64 TP3805 | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Copper Cu 64 TP3805 PET/CT)
- description
- Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later.
- interventionNames
- Drug: Copper Cu 64 TP3805
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
Primary outcomes (1)
- measure
- Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
- timeFrame
- Up to 4 weeks post-intervention
- description
- For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Must have diagnosis of urothelial cancer * Scheduled for extirpative surgery or biopsy of suspected metastatic lesion * Women of reproductive potential must have a urine pregnancy test day of injection * Men of reproductive potential must use condoms Exclusion Criteria: * Pregnancy or lactation * Known allergic reactions to components of the study product(s) * Treatment with another investigational drug or other intervention with 24 hours of injection * Must not have had an injection of a radioisotope 24 hours prior to exam
References
Publications (0)
Data not yet available
No reference posted for this study.