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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 190 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04838613
The ClinicalTrials.gov registry entry for NCT04838613 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which [68Ga]Ga-PSMA-11 is the first listed.
NCT04838613 reports 0 study locations.
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.
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