RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07039526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and Female patients 18 years of age and older
  2. 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. 3. Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
  4. 4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
  5. 5. Willingness of research participant or legal guardian/representative to give written informed consent.
  1. 1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
  2. 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. 3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection
  4. 4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

Contacts and Locations

Study Contact

John Waters, M.D.
CONTACT
214-645-7700
john.waters@utsouthwestern.edu

Principal Investigator

John Waters, M.D.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

Clemments University Hospital
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: John Waters

  • John Waters, M.D., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-08-19
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Esophageal Cancer
  • Gastrointestinal Cancers
  • Gynecologic Cancers