Phase 2
Completed N=23
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Source: ClinicalTrials.gov NCT04410367 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds — 100; 100; 100; 100 percentage of participants
Summary
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds |
100; 100; 100; 100; 100; 90 | — |
| PRIMARY Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds |
0; 0; 0; 38.5; 30.8; 46.2 | — |
| SECONDARY Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake |
80; 80; 80; 0; 0; 0 | — |
| SECONDARY Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. |
84.6; 84.6; 84.6; 100; 100; 100 | — |
| SECONDARY Treatment-emergent Adverse Events |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Previous history of solid tumor brain metastasis of any origin
- Histopathological confirmation of the primary solid tumor or a metastatic site
- Previous radiation therapy of brain metastatic lesion(s)
- A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
- Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy
Exclusion Criteria
- Patients with a history of active hematological malignancy
Data sourced from ClinicalTrials.gov (NCT04410367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.