TriangleNCT03739684 · OUTCOME
Correct Localization Rate (CLR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Within 60 days following 18F-DCFPyL PET/CT imaging.
What was measured
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
Analysis population: Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
Groups in this outcome
18F-DCFPyL Injection
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
| Group | Source count |
|---|---|
| 18F-DCFPyL Injection | 208 |
Reported measurements
Central Reader 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 18F-DCFPyL Injection | 85.6 | Not reported | 78.8 | 92.3 | Not reported |
Central Reader 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 18F-DCFPyL Injection | 87.0 | Not reported | 80.4 | 93.6 | Not reported |
Central Reader 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 18F-DCFPyL Injection | 84.8 | Not reported | 77.8 | 91.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.8
- upper Limit
- 92.3
- value
- 85.6
- title
- Central Reader 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.4
- upper Limit
- 93.6
- value
- 87.0
- title
- Central Reader 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.8
- upper Limit
- 91.9
- value
- 84.8
- title
- Central Reader 3
- denoms
- counts
- group Id
- OG000
- value
- 208
- units
- Participants
- description
- The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- id
- OG000
- title
- 18F-DCFPyL Injection
- param Type
- NUMBER
- population Description
- Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
- reporting Status
- POSTED
- time Frame
- Within 60 days following 18F-DCFPyL PET/CT imaging.
- title
- Correct Localization Rate (CLR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice