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0 Diseases | | 1 Product |
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3 Trials |  |
26 News |  |
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial completion date, Trial primary completion date: Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov) - Mar 27, 2024
P1, N=30, Recruiting, Sponsor: Nader Sanai
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- || ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Review, Journal: Theranostic Uses of the Heme Pathway in Neuro-Oncology: Protoporphyrin IX (PpIX) and Its Journey from Photodynamic Therapy (PDT) through Photodynamic Diagnosis (PDD) to Sonodynamic Therapy (SDT). (Pubmed Central) - Feb 24, 2024
This review describes the creation and evolution of ALA PDT, from the treatment of skin cancers to PDD and PDT of malignant brain tumors and, most recently, into a noninvasive form of PDT, ALA SDT. Current clinical trials of ALA SDT for recurrent glioblastoma and high-grade gliomas in adults, and the first pediatric ALA SDT clinical trial for a lethal brainstem cancer, diffuse intrinsic pontine glioma (DIPG), are also described.
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Phase classification, Combination therapy: A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov) - Feb 15, 2024
P2, N=40, Recruiting, Sponsor: SonALAsense, Inc.
Current clinical trials of ALA SDT for recurrent glioblastoma and high-grade gliomas in adults, and the first pediatric ALA SDT clinical trial for a lethal brainstem cancer, diffuse intrinsic pontine glioma (DIPG), are also described. Phase classification: P1/2 --> P2
- ||| ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Enrollment closed, Enrollment change, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - Feb 14, 2024
P1/2, N=8, Active, not recruiting, Sponsor: SonALAsense, Inc.
Phase classification: P1/2 --> P2 Recruiting --> Active, not recruiting | N=44 --> 8
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Interim report of a phase 1/2 study of sonodynamic therapy (SDT) using aminolevulinic acid (ALA) and low-intensity focused ultrasound in pediatric patients with diffuse intrinsic pontine glioma (DIPG) (Exhibit Hall A/B) - Nov 11, 2023 - Abstract #SNO2023SNO_838;
As expected, the PK for SONALA-001 demonstrate rapid infusion and clearance, whereas for PpIX, the PK are consistent with formation of a metabolite. Clinical trial enrollment is ongoing and dose-escalation cohorts will provide additional PK and safety data.
- ||| ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Phase classification, Enrollment change, Combination therapy: A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov) - May 11, 2023
P1/2, N=27, Recruiting, Sponsor: SonALAsense, Inc.
Clinical trial enrollment is ongoing and dose-escalation cohorts will provide additional PK and safety data. Phase classification: P2 --> P1/2 | N=18 --> 27
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Phase 1/2, first-in-child study of sonodynamic therapy (SDT) using low intensity focused ultrasound and 5-aminolevulinic acid (ALA) for patients with diffuse intrinsic pontine glioma. (On Demand | Hall A; Poster Bd # 374a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_4076;
P1/2
Patients with evidence of disease progression, diagnosis of porphyria, or prior or concurrent therapy with any other anticancer or investigational intervention will be excluded. Cohort 1 has been completed without DLT.
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial completion date, Trial primary completion date, Combination therapy: A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov) - Apr 3, 2023
P2, N=18, Recruiting, Sponsor: SonALAsense, Inc.
Cohort 1 has been completed without DLT. Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: May 2024 --> Aug 2024
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial completion date, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - Mar 31, 2023
P1/2, N=50, Recruiting, Sponsor: SonALAsense, Inc.
Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: May 2024 --> Aug 2024 Trial completion date: May 2026 --> Nov 2026
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial completion date, Trial primary completion date: Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov) - Mar 8, 2023
P1, N=30, Recruiting, Sponsor: Nader Sanai
Trial completion date: May 2026 --> Nov 2026 Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Phase classification, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - Jan 10, 2023
P1/2, N=50, Recruiting, Sponsor: SonALAsense, Inc.
Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Phase classification: P2 --> P1/2
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial initiation date, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - Dec 5, 2022
P2, N=50, Recruiting, Sponsor: SonALAsense, Inc.
Phase classification: P2 --> P1/2 Initiation date: Sep 2022 --> Jan 2023
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
A first-in-human phase 0/1 trial of 5-Aminolevulinic Acid Sonodynamic Therapy (5-ALA SDT) in recurrent glioblastoma (Ballroom B) - Sep 28, 2022 - Abstract #SNO2022SNO_1291;
This first-in-human Phase 0/1 study of a new therapeutic modality for rGBM patients demonstrates that 5-ALA SDT is safe at 200 to 800J and likely induces targeted cell death in rGBM patients via oxidative stress. At 10mg/kg of 5-ALA, the OBD is at or lower than 200J.
- || ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Enrollment open, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - Sep 26, 2022
P2, N=50, Recruiting, Sponsor: SonALAsense, Inc.
At 10mg/kg of 5-ALA, the OBD is at or lower than 200J. Not yet recruiting --> Recruiting
- || ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
New P2 trial, Combination therapy: A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov) - May 11, 2022
P2, N=50, Not yet recruiting, Sponsor: SonALAsense, Inc.
- || ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Enrollment open, Combination therapy: A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov) - May 5, 2022
P2, N=18, Recruiting, Sponsor: SonALAsense, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Trial completion date, Trial primary completion date: Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov) - Mar 14, 2022
P1, N=30, Recruiting, Sponsor: Nader Sanai
Not yet recruiting --> Recruiting Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
5-ALA Sonodynamic Therapy for Glioblastoma (GBR 101+102, 1F) - Mar 12, 2022 - Abstract #WFNOS2022WFNOS_335;
- ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
A First-in-Human Phase 0/1 Clinical Trial of 5-Aminolevulinic Acid Sonodynamic Therapy in Recurrent Glioblastoma (Exhibit Hall D) - Nov 16, 2021 - Abstract #SNO2021SNO_356;
Six hours prior to SDT, adult patients with recurrent GBM are administered Sonala-001 (10mg/kg), an IV formulation of 5-ALA...This first-in-human experience with a new therapeutic modality for recurrent glioblastoma patients demonstrates that 5-ALA SDT is safe at 200J. Sonodynamic therapy leads to targeted oxidative stress and tumor cell death in human glioblastoma tissue.
- || ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
New P2 trial, Combination therapy: A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov) - Nov 16, 2021
P2, N=18, Not yet recruiting, Sponsor: SonALAsense, Inc.
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
Enrollment open: Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov) - Dec 10, 2020
P1, N=30, Recruiting, Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sonodynamic therapy leads to targeted oxidative stress and tumor cell death in human glioblastoma tissue. Not yet recruiting --> Recruiting
- | ALA sonodynamic therapy / INSIGHTEC, SonALAsense, Ivy Brain Tumor Center
New P1 trial: Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov) - Sep 22, 2020
P1, N=30, Not yet recruiting, Sponsor: St. Joseph's Hospital and Medical Center, Phoenix