TriangleNCT02599194 · STUDY IN CONTEXT
18F-FSPG PET/CT for Cancer Patients on Therapy
Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- trial label
- 18F-FSPG PET/CT for Cancer Patients on Therapy
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0000
- source section id
- NCT02599194-om-0000
- source outcome index
- 0
- endpoint
- Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
- endpoint definition
- Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
- time origin
- Baseline and up to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis "mean of differences" would have a dispersion, but an analysis for "difference of means" is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0001
- source section id
- NCT02599194-om-0001
- source outcome index
- 1
- endpoint
- Number of Treatment-Related Adverse Events
- endpoint definition
- Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
- time origin
- Baseline to up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0002
- source section id
- NCT02599194-om-0002
- source outcome index
- 2
- endpoint
- Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
- endpoint definition
- Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
- time origin
- Baseline and up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- * Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). * Lesions detected at either before or after treatment only are reported as the difference from zero.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 18F-FSPG and 18F-FDG Intragroup Comparision
- regimen
- Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02599194-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 18F-FSPG and 18F-FDG Intragroup Comparision
- regimen
- Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02599194-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Difference in Lesion Size as Detected by 18F-FSPG
- regimen
- Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02599194-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Difference in Lesion Size as Detected by 18F-FDG
- regimen
- Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02599194-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-3933de68
- nct id
- NCT02599194
- harm key
- EG000
- source section id
- NCT02599194-ae
- event group key
- EG000
- event group label
- 18F-FSPG and 18F-FDG Intragroup Comparision
- serious affected
- 0
- serious at risk
- 7
- other affected
- 1
- other at risk
- 7
- frequency threshold
- 0
- collection period
- 30 days
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice