[18F]FET PET for Differentiating Tumor Progression vs Treatment-Related Changes in Brain Metastases
NCT07931261, Phase 3, Not yet recruiting, Telix Pharmaceuticals (Innovations) Pty Limited
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | [18F]FET PET for Differentiating Tumor Progression vs Treatment-Related Changes in Brain Metastases | ClinicalTrials.gov |
| NCT number | NCT07931261 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 381 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Telix Pharmaceuticals (Innovations) Pty Limited | ClinicalTrials.gov |
| Conditions | Brain Metastasis, Radiation Necrosis, Pseudoprogression, Tumor Progression | ClinicalTrials.gov |
| Interventions | Floretyrosine F 18 ([18F]FET) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images | From Day 1 through Day 2 (±1 day) follow-up | The patient-level mean Dice Similarity Coefficient (DSC), derived from all evaluable lesions, will be used to assess lesion spatial agreement between each reduced-dose \[18F\]FET PET dataset and the full-dose reference scan. The DSC results will be used to identify the lowest \[18F\]FET dose demonstrating non-inferior lesion spatial agreement. | ClinicalTrials.gov |
| Primary | Sensitivity of [18F]FET PET for Distinguishing Tumor Progression From Treatment-Related Changes Compared With CSOT | From baseline Day 1 through CSOT determination (approximately 2-3 months). | Sensitivity will be assessed for \[18F\]FET PET at the optimized dose for distinguishing tumor progression from treatment-related changes, using the Composite Standard of Truth (CSOT) as the reference standard. | ClinicalTrials.gov |
| Secondary | Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET | From Day 1 through Day 2 (±1 day) follow-up | The incidence and severity of adverse events and other safety findings will be assessed following administration of 740 MBq (±10%) \[18F\]FET PET | ClinicalTrials.gov |
| Secondary | Inter-Reader Agreement for [18F]FET PET Classification at the Optimized Dose | Baseline Day 1 through completion of image interpretation following CSOT determination (approximately 2-3 months | Inter-reader agreement will be assessed for interpretation of \[18F\]FET PET images obtained at the optimized dose. | ClinicalTrials.gov |
| Secondary | Lesion-Level Sensitivity of [18F]FET PET for Distinguishing Tumor Progression From Treatment-Related Changes | From baseline Day 1 through CSOT determination, approximately 2-3 months | Sensitivity will be assessed at the lesion level for distinguishing tumor progression from treatment-related changes | ClinicalTrials.gov |
| Secondary | Sensitivity of [18F]FET PET Compared With Histopathologic Confirmation | From baseline Day 1 through histopathologic confirmation, approximately 2-3 months | Sensitivity of \[18F\]FET PET will be assessed using histopathologic confirmation as the reference in participants with available histopathology. | ClinicalTrials.gov |
| Secondary | Positive Predictive Value of [18F]FET PET for Tumor Progression Compared With CSOT | From baseline Day 1 through CSOT determination, approximately 2-3 months | Positive predictive value will be assessed for \[18F\]FET PET classification of tumor progression using the Composite Standard of Truth (CSOT) as the reference standard | ClinicalTrials.gov |
| Secondary | Negative Predictive Value of [18F]FET PET for Tumor Progression Compared With CSOT | From baseline Day 1 through CSOT determination, approximately 2-3 months | Negative predictive value will be assessed for \[18F\]FET PET classification of tumor progression using the Composite Standard of Truth (CSOT) as the reference standard. | ClinicalTrials.gov |
| Secondary | Maximum Standardized Uptake Value (SUVmax) of [18F]FET PET Lesions | Baseline Day 1 imaging assessment | SUVmax will be measured for evaluable lesions on \[18F\]FET PET. | ClinicalTrials.gov |
| Secondary | Mean Standardized Uptake Value (SUVmean) of [18F]FET PET Lesions | Baseline Day 1 imaging assessment | SUVmean will be measured for evaluable lesions on \[18F\]FET PET. | ClinicalTrials.gov |
| Secondary | Maximum Tumor-to-Brain Ratio (TBRmax) of [18F]FET PET Lesions | Baseline Day 1 imaging assessment | TBRmax will be measured for evaluable lesions on \[18F\]FET PET. | ClinicalTrials.gov |
| Secondary | Mean Tumor-to-Brain Ratio (TBRmean) of [18F]FET PET Lesions | Baseline Day 1 imaging assessment | TBRmean will be measured for evaluable lesions on \[18F\]FET PET. | ClinicalTrials.gov |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) at the Optimized Dose | From Day 1 administration through study completion, approximately 5-6 months | Safety and tolerability at the optimized dose will be assessed by the number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events leading to treatment discontinuation, and treatment-related adverse events, as applicable. Adverse events will be assessed and graded according to the protocol-specified safety assessment criteria. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)