A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
Cuvinte cheie
Abstract
Descriere
The investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery.
The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.
Datele
| Ultima verificare: | 04/30/2020 |
| Primul depus: | 09/11/2016 |
| Inscriere estimată trimisă: | 09/13/2016 |
| Prima postare: | 09/14/2016 |
| Ultima actualizare trimisă: | 05/03/2020 |
| Ultima actualizare postată: | 05/05/2020 |
| Data actuală de începere a studiului: | 02/12/2017 |
| Data estimată de finalizare primară: | 12/30/2020 |
| Data estimată de finalizare a studiului: | 12/30/2020 |
Stare sau boală
Intervenție / tratament
Drug: ABY-029
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Experimental: ABY-029 ABY-029 will be administered prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue. | Drug: ABY-029 Using a sample size of 6-12 patients, ABY-029 will be administered via single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. Microdose levels of ABY-029 have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. Administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure. |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion Criteria: 1. Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery. 2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. 3. Valid informed consent by subject. 4. Age ≥ 18 years old. Exclusion Criteria: 1. Pregnant women or women who are breast feeding. 2. Patients on any experimental anti-EGFR targeted therapies |
Rezultat
Măsuri de rezultate primare
1. signal detection [during procedure]
Măsuri de rezultate secundare
1. diagnostic accuracy of ABY-029 detection [during procedure]
2. molecular uptake [during procedure]
