Recruiting NCT06511037
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Cancer, Peritoneal Carcinomatosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
Overview
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.
Interventions
- Drug Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
Given IV
Primary outcome measures
- Cytoreduction (CC) Score [Time frame: 1 year]
- Sensitivity-True Positive Rate (TPR) [Time frame: 1 year]
- Specificity-True Negative Rate (TNR) [Time frame: 1 year]
- Positive Predictive Value (PPV) [Time frame: 1 year]
- Negative Predictive Value (NPV) [Time frame: 1 year]
- Accuracy [Time frame: 1 year]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 30 days]
Eligibility criteria
Inclusion 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 restrictions
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange
Identifiers
NCT: NCT06511037 · 4951 · UCI 23-184