Recruiting
Phase 2

Pafolacianine

Sponsor:

John Waters

Code:

NCT07039526

Conditions

Esophageal Cancer

Gastrointestinal Cancers

Gynecologic Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYTALUX™ (pafolacianine) injection preoperatively

Study Details

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 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.

Conditions

Esophageal Cancer

Gastrointestinal Cancers

Gynecologic Cancers

Study ID

NCT07039526

Start date

Aug 19, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CYTALUX™ (pafolacianine) injection group

Single arm study, every patient receives the study intervention.

Interventions

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 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 and Locations

Central contacts

Locations

Clemments University Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

John Waters, M.D.

More Information

Sponsor

John Waters

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Pafolacianine
  • CYTALUX
  • Folate receptor-alpha
  • Near-infrared fluorescence imaging
  • Intraoperative imaging
  • Fluorescence-guided surgery
  • esophageal cancer
  • gastrointestinal cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by John Waters on 2026-06-05.