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Trial Title:
PhI Pilot Study Pafolacianine Injec for Intraoperative Imag Gastrointestinal Can Peritoneal Carcinomatosis
NCT ID:
NCT06511037
Condition:
Gastrointestinal Cancer
Peritoneal Carcinomatosis
Conditions: Official terms:
Gastrointestinal Neoplasms
Carcinoma
Peritoneal Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
Description:
Given IV
Arm group label:
Pafolacianine (CYTALUX)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chao Family Comprehensive Cancer Center, University of California, Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Start date:
October 31, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
University of California, Irvine
Agency class:
Other
Collaborator:
Agency:
On Target Laboratories
Agency class:
Other
Source:
University of California, Irvine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511037
