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Clinical Trial NCT07039526 for Esophageal Cancer, Gastrointestinal Cancers, Gynecologic Cancers is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer. Phase 2 50 Investigator-Initiated Single Dose

Recruiting
Clinical Trial NCT07039526 is designed to study Diagnostic for Esophageal Cancer, Gastrointestinal Cancers, Gynecologic Cancers. It is a Phase 2 interventional study that is recruiting, having started on 19 August 2025, with plans to enroll 50 participants. Led by John Waters, it is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 24 September 2025.
Brief 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 t...Show More
Detailed Description
Background and Rationale:

Gastroesophageal and pancreatic cancers are aggressive malignancies with limited curative options. Complete surgical resection (R0) remains the cornerstone of curative intent. However, current intraoperative tools-visual inspection, palpation, and endoscopy-are limited in accurately delineating tumor margins and detecting occult lesions. High recurrence rates after surgery suggest a need fo...

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Official Title

Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.

Conditions
Esophageal CancerGastrointestinal CancersGynecologic Cancers
Other Study IDs
  • STU20250049
NCT ID Number
NCT07039526
Start Date (Actual)
2025-08-19
Last Update Posted
2025-09-24
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Pafolacianine
CYTALUX
Folate receptor-alpha
Near-infrared fluorescence imaging
Intraoperative imaging
Fluorescence-guided surgery
esophageal cancer
gastrointestinal cancer
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCYTALUX™ (pafolacianine) injection group
Single arm study, every patient receives the study intervention.
CYTALUX™ (pafolacianine) injection preoperatively
CYTALUX™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye as a solution in vials containing 1.6 mL at 2 mg/mL. Each subject will be administered a single intravenous dose of not less than 1 hours before and not more than 24 hours before initiation of intraoperative NIR fluorescent imaging.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation
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.
Day 1 intra-operatively post intervention
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of lesions that are simultaneously fluorescence positive and cancer positive
NIR Imaging will take place at least 1 hour but no more than 24 hours after the end of the administration
Day 1 intra-operatively post intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Male and Female patients 18 years of age and older
  2. Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery.
  3. Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
  4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
  5. Willingness of research participant or legal guardian/representative to give written informed consent.

  1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
  2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
  3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection
  4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
John Waters logoJohn Waters
On Target Laboratories, LLC logoOn Target Laboratories, LLC
Study Responsible Party
John Waters, Sponsor-Investigator, MD, Assistant Professor, Cardiothoracic Surgery, University of Texas Southwestern Medical Center
Study Central Contact
Contact: John Waters, M.D., 214-645-7700, [email protected]
1 Study Locations in 1 Countries

Texas

Clemments University Hospital, Dallas, Texas, 75235, United States
Cesia Rodriguez, Contact, 214-645-5799, [email protected]
John Waters, M.D., Principal Investigator
Recruiting