Health TrialsbyHealthPanel

Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

ConditionsGastrointestinal CancerGastric CancerEsophageal CancerAppendiceal Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years of age and older of any sex.

Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2).

Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease burden.

Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.

Disqualifiers

Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject.

History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.

History of allergy to any of the components of CYTALUX™ (pafolacianine) injection.

Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule.

Trial design

Design model

Single group

Treatments tested in this trial

  • CYTALUX™ (pafolacianine)

    Drug

    All subjects participating in the study are expected to receive CYTALUX™ (pafolacianine) injection and standard care surgery; 1 to 24 hours after CYTALUX™ (pafolacianine) injection infusion is completed, all tumors planned to be removed as part of standard care will undergo assessment with NIR light imaging both intraoperatively and on the back table following surgery.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: CYTALUX™ (pafolacianine)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging

Determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients.

Time frame
12 months

Secondary outcomes

1

Number of Lesions

Number of lesions that are simultaneously fluorescence positive and cancer positive.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

On Target Laboratories, LLC

Collaborator

Source ClinicalTrials.gov
Apply now