PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

NCT06511037 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 4951UCI 23-184
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (6)

• Cytoreduction (CC) Score

  Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.

  1 year

• Sensitivity-True Positive Rate (TPR)

  Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.

  1 year

• Specificity-True Negative Rate (TNR)

  Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.

  1 year

• Positive Predictive Value (PPV)

  Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.

  1 year

• Negative Predictive Value (NPV)

  Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer.

  1 year

• Accuracy

  Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled.

  1 year

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  30 days

Study Arms (1)

Pafolacianine (CYTALUX)

EXPERIMENTAL

All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.

Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

Interventions

Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging DRUG

Given IV

Pafolacianine (CYTALUX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• On Target Laboratories: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Peritoneal Neoplasms

Interventions

Pafolacianine; X-Rays

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Maheswari Senthil, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)