A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 04/30/2020 |
| Primer enviat: | 09/11/2016 |
| Inscripció estimada enviada: | 09/13/2016 |
| Publicat per primera vegada: | 09/14/2016 |
| Última actualització enviada: | 05/03/2020 |
| Publicació de l'última actualització: | 05/05/2020 |
| Data d'inici de l'estudi real: | 02/12/2017 |
| Data estimada de finalització primària: | 12/30/2020 |
| Data estimada de finalització de l’estudi: | 12/30/2020 |
Condició o malaltia
Intervenció / tractament
Drug: ABY-029
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. signal detection [during procedure]
Mesures de resultats secundaris
1. diagnostic accuracy of ABY-029 detection [during procedure]
2. molecular uptake [during procedure]
