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Updated: Jun 19, 2026

Establishing Intracranial Brain Tumor Xenografts With Subsequent Analysis of Tumor Growth and Response to Therapy using Bioluminescence Imaging
Published on: July 13, 2010
Design and conduct of theranostic trials in neuro-oncology: Challenges and opportunities
Patrick Y Wen1, Matthias Preusser2, Nathalie L Albert3
1Center For Neuro-Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA.
Abstract:
Theranostics is a new treatment modality integrating molecular imaging with targeted radionuclide therapy. Theranostic agents have received regulatory approval for some systemic cancers and have therapeutic potential in neuro-oncology. As clinical trials are developed to evaluate the efficacy of theranostic agents in brain tumors, specific considerations will have to be considered, taking into account lessons learned from previous studies examining other treatment modalities in neuro-oncology. These include the need for molecular imaging or surgical window-of-opportunity studies to confirm adequate passage across the blood-brain barrier, optimize eligibility criteria, and selection of the most appropriate response criteria and endpoints to address issues such as pseudoprogression. This review will discuss some of the issues that should be considered when designing clinical trials for theranostic agents.
Insights
Theranostics combines molecular imaging and targeted radionuclide therapy for cancer treatment. Designing clinical trials for brain tumors requires careful consideration of the blood-brain barrier and response criteria.
Area of Science:
- Oncology
- Nuclear Medicine
- Radiology
Background:
- Theranostics integrates molecular imaging and targeted radionuclide therapy.
- Approved agents exist for systemic cancers, with potential in neuro-oncology.
- Brain tumor clinical trials require specific considerations.
Purpose of the Study:
- To discuss key issues in designing clinical trials for theranostic agents in neuro-oncology.
- To highlight the need for specialized approaches in brain tumor theranostics.
Main Methods:
- Review of existing literature and clinical trial methodologies in neuro-oncology.
- Discussion of challenges specific to brain tumor treatment evaluation.
Main Results:
- Clinical trials for brain tumors necessitate evaluation of blood-brain barrier penetration.
- Optimizing eligibility criteria and response assessments (e.g., pseudoprogression) is crucial.
- Lessons from other neuro-oncology treatments inform theranostic trial design.
Conclusions:
- Designing effective theranostic clinical trials for brain tumors requires addressing unique challenges.
- Molecular imaging and careful endpoint selection are vital for success.
- Further research is needed to optimize theranostic agent application in neuro-oncology.
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