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NCT05363826 · ClinicalTrials.gov registry record · Phase 1
Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®
A Phase 1 study of Glioblastoma Multiforme of Brain and Glioma, Sarcomatous, sponsored by Photolitec.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05363826 is a Phase 1 study of Glioblastoma Multiforme of Brain and Glioma, Sarcomatous that is actively recruiting participants, run by Photolitec. The registered enrollment target is 30 participants, below the 156-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05363826, a Phase 1 study of Glioblastoma Multiforme of Brain and Glioma, Sarcomatous, is actively recruiting participants, sponsored by Photolitec.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective. Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success. For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that: 1. has no significant systemic toxicity apart from some temporary skin photosensitivity, 2. crosses the blood brain barrier, 3. accumulates to a high level in glioblastoma and minimally in the brain, 4. is activated by the wavelength of light that penetrates most deeply into the brain, 5. minimizes any temporary skin photosensitivity. Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.
Conditions Studied
Interventions
- COMBINATION_PRODUCT photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)
Study Locations (1)
New York
- Roswell Park Cancer - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-04-11 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05363826
The ClinicalTrials.gov registry entry for NCT05363826 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (81% lower). The listed sponsor is Photolitec, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Glioblastoma Multiforme of Brain appearing as the primary indexed condition, and to 1 intervention - of which photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) is the first listed.
NCT05363826 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05363826 about?
NCT05363826 is a clinical study titled "Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®". This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective. Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers wi...
What is the current status of trial NCT05363826?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-04-11. Estimated completion is 2026-05.
What conditions does trial NCT05363826 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme of Brain, Glioma, Sarcomatous.
What interventions are being tested in trial NCT05363826?
The interventions under investigation include: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05363826?
This trial is sponsored by Photolitec, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05363826 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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