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.
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- John Waters, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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What this trial measures
- 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.