Clinical trial NCT06511037: PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
Official title: The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Cancer
Peritoneal Carcinomatosis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: On Target Laboratories
First posted: 2024-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Cytoreduction (CC) Score
timeFrame: 1 year
measure: Sensitivity-True Positive Rate (TPR)
timeFrame: 1 year
measure: Specificity-True Negative Rate (TNR)
timeFrame: 1 year
measure: Positive Predictive Value (PPV)
timeFrame: 1 year
measure: Negative Predictive Value (NPV)
timeFrame: 1 year
measure: Accuracy
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 30 days
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Maheswari Senthil, MD
role: PRINCIPAL_INVESTIGATOR
References: