RECRUITING

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Conditions

Osteosarcoma Pulmonary Metastasis Fluorescence Metastatic Sarcoma Pediatrics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy

Quick Facts

Study Start:2024-04-08

Study Completion:2026-01-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06235125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Patients 6-17 years of age at the time of study enrollment 2. Willingness of research participant or legal guardian/representative to give written informed consent 3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent 4. Patient weight greater than or equal to 20 kg 5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma 6. 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. 7. 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. 8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention 9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.	1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. 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. 3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION 4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule 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 except in subjects with Gilbert's syndrome. 7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration 8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7). 9. Participants will be excluded if their 12th or 18th birthday would occur during study participation 10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.

Inclusion Criteria

Exclusion Criteria

1. Patients 6-17 years of age at the time of study enrollment
2. Willingness of research participant or legal guardian/representative to give written informed consent
3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent
4. Patient weight greater than or equal to 20 kg
5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma
6. 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.
7. 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.
8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention
9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.

1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
2. 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.
3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION
4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
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 except in subjects with Gilbert's syndrome.
7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration
8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7).
9. Participants will be excluded if their 12th or 18th birthday would occur during study participation
10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.

Contacts and Locations

Study Contact

Timothy Lautz, MD

CONTACT

312-227-4210

tlautz@luriechildrens.org

Seth Goldstein, MD

CONTACT

312-227-4210

sgoldstein@luriechildrens.org

Principal Investigator

Timothy Lautz, MD

PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Timothy Lautz, MD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08

Study Completion Date2026-01-20

Study Record Updates

Study Start Date2024-04-08

Study Completion Date2026-01-20

Terms related to this study

Additional Relevant MeSH Terms

Osteosarcoma
Pulmonary Metastasis
Fluorescence
Metastatic Sarcoma
Pediatrics