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

Part of paid clinical trials in Dallas, Texas.

Sponsor
John Waters
Study ID
NCT07039526
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CYTALUX™ (pafolacianine) injection preoperatively — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 19, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CYTALUX™ (pafolacianine) injection group
    Single arm study, every patient receives the study intervention.

Primary Outcome Measure

Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation [ Time Frame: Day 1 intra-operatively post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clemments University HospitalDallasTexas75235
Cesia Rodriguez
[email protected]
214-645-5799
John Waters, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Clemments University Hospital· Dallas, TX

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