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Kaartweergave
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures Vroege fase 1 30
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De klinische studie NCT07493447 onderzoekt ondersteunende zorg bij meningeoom, Glioblastoom, Akoestisch neuroom, Hersenkanker, Hypofyseadenoom. Deze Vroege fase 1 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 30 deelnemers begint op 2 mei 2026. De studie wordt geleid door Eben Rosenthal en de voltooiing is gepland op 2 juni 2031. Laatste update op ClinicalTrials.gov: 25 maart 2026.
Beknopte samenvatting
This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.
Uitgebreide beschrijving
This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the in...Toon meer
Officiële titel
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Aandoeningen
meningeoomGlioblastoomAkoestisch neuroomHersenkankerHypofyseadenoomAndere studie-ID's
- VICCHN25072
NCT-ID
Startdatum (Werkelijk)
2026-05-02
Laatste update geplaatst
2026-03-25
Verwachte einddatum
2031-06-02
Inschrijving (Geschat)
30
Studietype
Interventioneel
FASE
Vroege fase 1
Status
Nog niet rekruterend
Trefwoorden
Cancer
Malignant
Benign
Glioblastoma
Meningioma
Pituitary Adenoma
Acoustic Neuroma
Brain Masses
Intracranial Lesion
Malignant
Benign
Glioblastoma
Meningioma
Pituitary Adenoma
Acoustic Neuroma
Brain Masses
Intracranial Lesion
Primaire doel
Ondersteunende zorg
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelStudy Arm - 50 mg pan800 Participants will receive a single 50 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring, postoperative pharmacokinetic blood draws, and adverse-event assessments through surgery and a Day 15 (±7) follow-up. | Panitumumab-IRDye800 Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion. |
ExperimenteelStudy Arm - 100 mg pan800 Participants will receive a single 100 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before their standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring along with postoperative pharmacokinetic and immunogenicity blood sampling and adverse-event assessments through surgery and the Day 15 (±7) follow-up visit. | Panitumumab-IRDye800 Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions. | Safety will be defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered definitely or probably related to pan800. Safety data will be summarized by grade, severity, and type. | From infusion to 15 days post-infusion. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue. | Efficacy will be measured by tumor-to-background ratio (TBR) using fluorescence intensity measurements. | Within 14 days post-surgery |
Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio. | There will be an assessment of tumor-to-background ratio (TBR) comparing cohort 1 \& 2. | Within 14 days post-surgery |
Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio. | There will be an assessment of tumor-to-background ratio (TBR). Some patients may receive the study drug on varying pre-surgery days rather than infusions on the same day for every patient. The TBR will be assessed for every patient regardless of pre-surgery infusion day. The optimal timing of administration of the study drug will be determined by the highest average TBR from a particular pre-surgery infusion day. TBR will still be assessed using the intraoperative fluorescence imaging taken on the standard of care surgery. | Within 14 days post-surgery |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.
Subject age ≥ 18 years.
Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:
- Chemistry Panel - Potassium, BUN (or urea), and Creatinine
- CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
- Magnesium and Phosphorus
Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.
Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.
- Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
- History of infusion reactions to any monoclonal antibody therapies.
- Women who are currently pregnant or breastfeeding.
- Participants presenting with a baseline QTcF interval > than 480 milliseconds.
- Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Patients with severe renal disease or anuria
Eben RosenthalVerantwoordelijke instantie
Eben Rosenthal, Sponsor-Onderzoeker, Barry and Amy Baker Professor and Chair, Vanderbilt-Ingram Cancer Center
Centraal Contactpersoon
Contact: Makenna Brown, 615-421-4370, [email protected]
Contact: Nicole Jones, 615-936-2807, [email protected]
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