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New treatment option for Gastrointestinal Cancer
Official title PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
ClinicalTrials.gov ID: NCT06511037
What this study is testing
What is Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging?
Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients 18 years of age and older
- Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
- Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study...
- Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of...
- Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and...
You likely can't join if
- Previous exposure to CYTALUX™ (PAFOLACIANINE)
- Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
- Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
- History of anaphylactic reaction
- History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
- Pregnancy, or positive pregnancy test
See the full eligibility criteria
- Adult patients 18 years of age and older
- Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
- Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
- Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
- Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study...
- Previous exposure to CYTALUX™ (PAFOLACIANINE)
- Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
- Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
- History of anaphylactic reaction
- History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
- Pregnancy, or positive pregnancy test
- Clinically significant abnormalities on ECG
- Impaired renal function defined as eGFR \<50 mL/min/1.73m2
- Impaired liver function defined as values \>3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
- Received an investigational agent in another trial within 30 days prior to surgery
- Known sensitivity to fluorescent light
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.