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NCT04838613 · ClinicalTrials.gov registry record · Phase 3
Study of Diagnostic Performance of [18F]CTT1057 in BCR
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
NCT04838613: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04838613 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 190 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838613, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
Study Summary
The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable \[18F\]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.
Primary Outcome
Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding.
Interventions
- DRUG [68Ga]Ga-PSMA-11
- DRUG [18F]CTT1057
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2023-11-23 |
| Phase | Phase 3 |
What the finished NCT04838613 record still lists
NCT04838613 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which [68Ga]Ga-PSMA-11 is the first listed.
NCT04838613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04838613 about?
NCT04838613 is a clinical study titled "Study of Diagnostic Performance of [18F]CTT1057 in BCR". The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard....
What is the current status of trial NCT04838613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2021-09-30. Estimated completion is 2023-11-23.
What interventions are being tested in trial NCT04838613?
The interventions under investigation include: [68Ga]Ga-PSMA-11 (DRUG), [18F]CTT1057 (DRUG).
Who is sponsoring clinical trial NCT04838613?
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 NCT04838613's enrollment target sits among peer trials
190 1402nd of 2000 higher than 593 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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