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NCT07039526 · ClinicalTrials.gov registry record · Phase 2
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
A Phase 2 study of Esophageal Cancer and Gynecologic Cancers, sponsored by John Waters.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07039526: Recruiting Phase 2 study of Esophageal Cancer and Gynecologic Cancers, sponsored by John Waters.
NCT07039526 is a Phase 2 study of Esophageal Cancer and Gynecologic Cancers that is actively recruiting participants, run by John Waters. The registered enrollment target is 50 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07039526, a Phase 2 study of Esophageal Cancer and Gynecologic Cancers, is actively recruiting participants, sponsored by John Waters.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. The main question it aims to answer is: • Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing surgical resection for cancer? Participants taking part in this study will receive the study medication. Then, during the surgery the investigator team will turn on the camera to evaluate if the tumor is visible with the help of the study medication. Taking part in this study will last about 2 months.
Primary Outcome
Proportion of subjects who have one or more NIR fluorescence positive lesion not detected under normal light and/or palpation will be measured in this outcome.
Conditions Studied
Interventions
- DRUG CYTALUX™ (pafolacianine) injection preoperatively
Study Locations (1)
Texas
- Clemments University Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-08-19 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT07039526 shows while recruiting
NCT07039526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which CYTALUX™ (pafolacianine) injection preoperatively is the first listed.
NCT07039526 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07039526 about?
NCT07039526 is a clinical study titled "Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.". The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, e...
What is the current status of trial NCT07039526?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2025-08-19. Estimated completion is 2027-12.
What conditions does trial NCT07039526 study?
This clinical trial studies the following conditions: Esophageal Cancer, Gynecologic Cancers, Gastrointestinal Cancers.
What interventions are being tested in trial NCT07039526?
The interventions under investigation include: CYTALUX™ (pafolacianine) injection preoperatively (DRUG).
Who is sponsoring clinical trial NCT07039526?
This trial is sponsored by John Waters, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07039526 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Esophageal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07039526's enrollment target sits among peer trials
50 75th of 123 higher than 47 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer 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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