Health TrialsbyHealthPanel

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

ConditionsOsteosarcomaPulmonary MetastasisFluorescenceMetastatic SarcomaPediatrics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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 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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Cytalux with Near Infrared ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day
2

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.

Time frame
1 day

Secondary outcomes

1

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

The proportion of subjects with one or more NIR-positive lesion(s), not detected under normal light and/or palpation, and subsequently determined on histologic evaluation to contain viable metastatic tumor

Time frame
1 day
2

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

Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE observed after administration of the study intervention and up to the follow-up period. The number of TEAEs will be collected to asses the safety and tolerability of single intravenous infusions/injection of CYTALUX™ (PAFOLACIANINE) INJECTION in children and adolescents

Time frame
30 days

Other outcomes

Sponsors and contacts

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

Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

On Target Laboratories, LLC

Collaborator

Source ClinicalTrials.gov
Apply now