Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

NCT06235125 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2023-6263
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.

Conditions

Osteosarcoma; Pulmonary Metastasis; Fluorescence; Metastatic Sarcoma; Pediatrics

Outcome Measures

Primary Outcomes (2)

• Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification

  In children and adolescents with histologically-confirmed cancer undergoing pulmonary surgery for suspected metastases, each excised pulmonary lesion will be classified by the surgeon as positive or negative on NIR imaging after administration CYTALUX™ (PAFOLACIANINE) and then subjected to routine histologic examination. Sensitivity will be assessed as the fraction of histologically-confirmed metastatic nodules which demonstrated positive NIR fluorescence.

  1 day

• False-Positive Rate of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification

  In children and adolescents with histologically-confirmed cancer undergoing pulmonary surgery for suspected metastases, each excised pulmonary lesion will be classified by the surgeon as positive or negative on NIR imaging after administration CYTALUX™ (PAFOLACIANINE) and then subjected to routine histologic examination. The false positive rate will be assessed as the fraction of NIR-positive nodules that have no viable malignancy on histologic examination.

  1 day

Secondary Outcomes (2)

• Detection of occult metastatic lesion(s) with Near-infrared (NIR) imaging after pafolacianine injection

  1 day

• Number of patients with treatment-emergent adverse events (TEAEs)

  30 days

Study Arms (1)

Cytalux with Near Infrared Imaging

EXPERIMENTAL

All participants will receive Cytalux and undergo near infrared imaging.

Drug: Cytalux

Interventions

Cytalux DRUG

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Also known as: Pafolacianine injection, OTL38 injection

Cytalux with Near Infrared Imaging

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients 6-17 years of age at the time of study enrollment
• Willingness of research participant or legal guardian/representative to give written informed consent
• Willingness of patients (subjects) age 12-17 to provide written adolescent assent
• Patient weight greater than or equal to 20 kg
• Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma
• Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging.
• Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception.
• Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention
• Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.

You may not qualify if:

• 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 also be excluded.
• 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
• 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) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
• Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration
• Participants will be excluded if their 12th or 18th birthday would occur during study participation

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• On Target Laboratories, LLC: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.

  PMID: 37019717 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma; Sarcoma

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Timothy Lautz, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Lautz, MD

CONTACT

312-227-4210; tlautz@luriechildrens.org

Seth Goldstein, MD

CONTACT

312-227-4210; sgoldstein@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Surgical Oncology

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 31, 2024
• Study Start: April 8, 2024
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)