Using CYTALUX (pafolacianine) with a near-infrared camera to help find cancer during surgery
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
This trial will test whether a single injection of CYTALUX (pafolacianine) helps surgeons see gastrointestinal, foregut, pancreatic, hepatobiliary, esophageal, and gynecologic cancers during surgery using a special near-infrared camera.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07039526 on ClinicalTrials.gov |
What this trial studies
This Phase 2 pilot gives adult surgical patients a single preoperative IV dose of CYTALUX (pafolacianine), a folate-receptor–targeted near-infrared fluorescent agent, and then uses an intraoperative NIR camera to visualize tumor tissue in real time. Participants are adults with a known or high clinical suspicion of GI, foregut, pancreatic, hepatobiliary, esophageal, or gynecologic malignancy who are scheduled for resection, debulking/HIPEC, or diagnostic laparoscopy. The surgical team records whether fluorescence improves detection of malignant tissue, including occult lesions and margin delineation, and participants are followed through the perioperative period for safety and imaging outcomes. The trial is single-dose and brief, with follow-up visits to document any adverse events and correlation of imaging with histopathology.
Who should consider this trial
Good fit: Adults (18+) with a known or highly suspected gastrointestinal, foregut, pancreatic, hepatobiliary, esophageal, or gynecologic cancer who are scheduled for surgical resection, debulking/HIPEC, or diagnostic laparoscopy and can safely receive CYTALUX are ideal candidates.
Not a fit: Patients whose tumors do not express folate receptor-alpha, those with a history of severe allergic reactions to indocyanine-green–like dyes, or patients not undergoing operative management are unlikely to benefit from this imaging intervention.
Why it matters
Potential benefit: If successful, this approach could help surgeons find and remove more cancer during the operation, potentially reducing missed disease and lowering recurrence risk.
How similar studies have performed: Other clinical work using pafolacianine and near-infrared imaging has shown promising intraoperative tumor visualization and CYTALUX is already FDA-approved for intraoperative visualization in certain settings, so this study applies that approach to additional cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Where this trial is running
Dallas, Texas
- Clemments University Hospital — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: John Waters, M.D. — University of Texas Southwestern Medical Center
- Study coordinator: John Waters, M.D.
- Email: john.waters@utsouthwestern.edu
- Phone: 214-645-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.