CYTALUX (Pafolacianine) for Detecting Cancer During Surgery

This study is testing an FDA-approved drug called CYTALUX (pafolacianine) to see if it can help surgeons find cancer cells during operations for certain cancers. CYTALUX attaches to cancer cells and "lights up" when viewed with a special camera, making it easier to see. The study wants to find out if using CYTALUX with this special imaging can improve how doctors detect cancerous tissue in adults undergoing surgery for gastrointestinal (stomach and intestines), foregut (upper digestive tract), pancreatic, hepatobiliary (liver and bile ducts), esophageal (food pipe), or gynecologic (female reproductive organs) cancers. You might be able to join if you are 18 or older and are having surgery for one of these cancers. The study is considered successful if a good number of patients have cancer spots light up that weren't seen before.

Study design
This is an interventional study planning to enroll 50 participants. It is a single-dose pilot study, meaning participants will receive one dose of the study drug.
What's involved
You will receive a single intravenous (IV) injection of CYTALUX (pafolacianine) between 1 and 24 hours before your surgery. The study will then observe if any cancer tissue lights up during your operation.
Compensation
Not stated in the trial record.
Follow-up
The main observation for this study happens on Day 1, during your surgery, to see if cancer tissue is detected.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07039526

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
John Waters
~50 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:CYTALUX™ (pafolacianine) injection preoperatively

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation
Measured over Day 1 intra-operatively post intervention
Esophageal Cancer
Gastrointestinal Cancers
Gynecologic Cancers
1 sites across 1 states
Texas1
  • John Waters, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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  • Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpationDay 1 intra-operatively post intervention

    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.