Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients (TumorGlow)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a phase 1 single dose, open-label study to determine the safety of a single 5 mg/kg dose of ICG (TumorGlow) used with Near Infrared (NIR) fluorescent for pediatric subjects with suspected metastatic sarcoma to the lung scheduled to undergo thoracic surgery per CT/PET or other imaging based on standard of care.
Following the screening visit to confirm eligibility, subject assent and parental/legal guardian consent for enrollment will be obtained prior to commencement of any study procedures. The screening period will be up to 60 days prior to ICG infusion. All subjects enrolled will be infused with 5 mg/kg ICG intravenously up to 5-days prior to the planned surgery (Day 0).
After ICG infusion is completed (Day 0), subjects during the surgery will undergo white light evaluation and/or palpation, and the number and the location of all suspicious nodules and lesions identified in this step will be recorded as such following the study procedure guideline as described in  (Day 1). Following white light assessment, but prior to any surgical removal of lesions/nodules, subjects will undergo assessment with NIR fluorescent light imaging to localize any lesions or nodules.
All identified lesions will be removed as determined by the surgeon. All removed lesions identified either using white light, NIR imaging or both will be documented as such and examined back table for fluorescence under NIR imaging including margin status. Positive margins are defined as fluorescent areas identified within (less than or equal to) 5mm of the inside staple line by back table measurement. Following the resection and prior to closing the subject, the field will be illuminated with the imaging system again to detect and remove any remaining fluorescence positive nodules. All specimens removed after the back table examination will be sent to pathology for evaluation including margin status by a pathologist that is blinded to the fluorescent status of lesions or nodules.
Type d'étude
Inscription (Estimé)
Phase
- Première phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Peter Mattei, MD
- Numéro de téléphone: (215)-590-2730
- E-mail: mattei@email.chop.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- 1. Male and female children (12 - 17 years of age) with a primary diagnosis, or a high clinical suspicion of a solid tumor with metastasis to the lung warranting surgery based on CT/PET or other imaging 2. Are scheduled to undergo surgical resection for suspected metastasis 3. Female subjects of childbearing potential (including those less than 2 years postmenopausal) agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG. Male subjects who are are sexually active (and capable of producing sperm) with a partner that could become pregnant, must agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG.
Exclusion Criteria:
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 ICG. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation 3. A positive serum pregnancy test at screening for female subjects of childbearing potential. Note that subjects with a positive pregnancy test on the day of infusion will be discontinued from study and will not receive the study drug.
4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 5. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome. *For subjects with Gilbert's syndrome, total bilirubin levels exceeding 3 mg/dL will be excluded.* 6. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 7. History of uncontrolled hypertension. (e.g., history of an emergency room [ER] admission for hypertensive crisis or ≥ 3 BP medications) 8. Known sensitivity to fluorescent light
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Single Dose 5mg/kg
Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.
|
Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: 1 year
|
To assess the safety and tolerability of intravenously infusion of a single dose 5 mg/kg of ICG; 2. To assess the safety and tolerability of using high dose (5 mg/kg) ICG used with Near Infrared (NIR) fluorescent imaging when used with ICG in subjects undergoing pulmonary metastasectomy.
Safety will be assessed by the incidence of AEs and SAEs coded using MedDRA.
Results will be summarized as the number and percentage of participants with events, categorized by preferred term, system organ class, severity grade, attribution, and timing relative to infusion and surgery.
AE rates will be reported with one-sided 90% exact confidence intervals and compared against a 25% unacceptable safety threshold.
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity of INR
Délai: 1 year
|
The following secondary efficacy endpoints are only defined for FAS subjects, i.e., subjects undergoing NIR fluorescent imaging with ICG for the detection of primary nodules and/or synchronous lesions
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25-023410
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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