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NCT00409214
A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma (Defined for the Purposes of the Protocol as Anaplastic Astrocytoma [AA] or Glioblastoma Multiforme [GBM]) Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
Phase 2 trial testing LS11 (talaporfin sodium) in Glioma in 18 participants. Completed.
1 February 2008
Quick facts
| Lead sponsor | Light Sciences Oncology |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 November 2006 |
| Primary completion | 1 February 2008 |
| Sites | 1 location across Serbia |
Drugs / interventions tested
- LS11 (talaporfin sodium) — full drug profile →
- Light source (interstitial light emitting diodes)
- Intraoperative placement of device in glioma
Conditions studied
- Glioma — all drugs for Glioma →
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
- Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →
Sponsor
Light Sciences Oncology — full company profile →
Who can join
18 and older, any sex, with Glioma or Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma
Sponsor's own description
The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00409214
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07405372 — Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas · recruiting
- NCT07338539 — BIO-SHORT: Biologically Guided Short-Course Hypofractionated RT for Poor-Prognosis GBM · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00409214 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Light Sciences Oncology
- Last refreshed: 14 November 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00409214.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing