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NCT06434909 · ClinicalTrials.gov registry record · Phase 2
CYTALUX™for the Intraoperative Imaging of Prostate Cancer
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT06434909: Completed Phase 2 study, sponsored by Indiana University.
NCT06434909 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06434909, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
Primary Outcome
The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes: 1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology. 2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy.
Interventions
- DRUG Cytalux™ (pafolacianine) for fluorescent imaging
- PROCEDURE Image Guided Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 2 |
What the finished NCT06434909 record still lists
NCT06434909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytalux™ (pafolacianine) for fluorescent imaging is the first listed.
NCT06434909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06434909 about?
NCT06434909 is a clinical study titled "CYTALUX™for the Intraoperative Imaging of Prostate Cancer". This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate canc...
What is the current status of trial NCT06434909?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2024-09-19. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT06434909?
The interventions under investigation include: Cytalux™ (pafolacianine) for fluorescent imaging (DRUG), Image Guided Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT06434909?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06434909's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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