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[18F]-ML-10 PET for Brain Metastases Response to SRS
NCT00696943Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 2008
- Primary completion
- Jul 2009
- Sponsor
- Aposense Ltd.
- Modality
- Radiopharmaceutical
- Drugs
- [18F]ML10
- Conditions
- brain metastases
01
Overview
Phase 2, open-label, single-arm trial of [18F]ML10 in brain metastases, sponsored by Aposense Ltd. Primary endpoint: Assessment of the change in the uptake of [18F]-ML-10 by the target lesion(s) in response to SRS at 3 months. Started Jul 2008; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
18F-ML-10
Single arm receiving [18F]-ML-10 PET/CT scans before and after SRS.
03
Who it enrols
Adult patients with metastatic non-hematological cancer and 1-4 brain metastases scheduled for SRS, with adequate organ function and no recent WBRT or concurrent temozolamide.
04
Endpoints
Primary
Assessment of the change in the uptake of [18F]-ML-10 by the target lesion(s) in response to SRS
Secondary
Assessment of the relationship between the change in uptake of [18F]-ML-10 and shrinkage of the metastatic target lesion
Evaluation of the safety of [18F]-ML-10
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