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NCT04838626 · ClinicalTrials.gov registry record · Phase 2
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT04838626: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04838626 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 195 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838626, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) were used for the histopathology assessments.
Primary Outcome
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
Interventions
- DRUG [18F]CTT1057
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2023-11-24 |
| Phase | Phase 2 |
What the finished NCT04838626 record still lists
NCT04838626 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 1 intervention - of which [18F]CTT1057 is the first listed.
NCT04838626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04838626 about?
NCT04838626 is a clinical study titled "Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection". The purpose of this study was to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during s...
What is the current status of trial NCT04838626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2021-09-07. Estimated completion is 2023-11-24.
What interventions are being tested in trial NCT04838626?
The interventions under investigation include: [18F]CTT1057 (DRUG).
Who is sponsoring clinical trial NCT04838626?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04838626's enrollment target sits among peer trials
195 350th of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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