Cancer in the Lung, Ovarian Cancer
Conditions
Keywords
cancer in the lung, lung cancer, ovarian cancer, lung cancer surgery, ovarian cancer surgery, CYTALUX, pafolacianine, fluorescent, molecular imaging
Brief summary
The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.
Detailed description
This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer. The study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer. Eligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows. During surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™. The primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).
Interventions
DRUGCYTALUX (pafolacianine) injection
CYTALUX™ (PAFOLACIANINE) INJECTION: folate analog ligand conjugated with an indole cyanine green-like dye. Each subject will be administered a single intravenous dose (0.025 mg/kg) based on their assigned cohort before initiation of intraoperative NIR fluorescent imaging
Sponsors
On Target Laboratories, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Lung and ovarian subjects will be classified equally into one of two dosing cohorts as defined below: * Lung Cohort 1: Subjects with malignant and non-malignant lesions in the lung dosed 1-24 hours prior to imaging * Lung Cohort 2: Subjects with malignant and non-malignant lesions in the lung dosed 120 - 168 hours prior to imaging * Ovarian Cohort 1: Subjects with ovarian cancer dosed 1-9 hours prior to imaging * Ovarian Cohort 2: Subjects with ovarian cancer dosed 120 - 168 hours prior to imaging
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients 18 years of age and older 2. Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer 3. Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction 4. Willingness of research participant or legal guardian/representative to give written informed consent
Exclusion criteria
1. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation. 2. History of allergy to any of the components of Cytalux™ (pafolacianine) 3. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule 4. Known sensitivity to fluorescent light 5. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 6. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin excluding those patients with Gilbert's syndrome 7. Pregnant and/or lactating women 8. Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor-to-background ratio | 1 day | Mean difference in in-situ tumor-to-background ratio (TBR) between 120-168 hours and the approved window |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 1 day | The sensitivity of Cytalux™ (pafolacianine) with NIR imaging for detection of malignant and non-malignant lung lesions and malignant ovarian cancer lesions. The sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer. |
| Sensitivity of folate receptor-positive lesions | 1 day | The sensitivity of Cytalux with NIR imaging for detection of malignant and non-malignant lung lesions and for malignant ovarian cancer lesions that are confirmed to be folate receptor alpha and/or folate receptor beta positive |
Contacts
CONTACTTina Barrett
Outcome results
None listed