TriangleNCT05968846 · OUTCOME
Measure of Interest
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From enrollment to the end of the study is 8 days
What was measured
For AL, ATTR and all patients, we will correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in disease status (progression, response, or stable state) when this can be established from data (serum biomarkers and cardiac imaging parameters) in the patients' medical record or collected during the AMY1001 trial. Disease status is categorized based on NTproBNP, creatinine, blood urea nitrogen or alkaline phosphatase compared to baseline values taken at the original scan time or noted in the medical record based on a sum of clinical findings. Progression is defined as a ≥30% increase; Response is defined as a ≥30% decrease; and Stable disease is defined as a \<30% increase or decrease.
Analysis population: No echocardiographic data was available from the baseline imaging session with which to compare changes in the quantitative uptake and there was no contemporaneous echocardiography data in the medical record contemporaneous with baseline imaging
Groups in this outcome
All Participants
Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys
| Group | Source count |
|---|---|
| All Participants | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- For AL, ATTR and all patients, we will correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in disease status (progression, response, or stable state) when this can be established from data (serum biomarkers and cardiac imaging parameters) in the patients' medical record or collected during the AMY1001 trial. Disease status is categorized based on NTproBNP, creatinine, blood urea nitrogen or alkaline phosphatase compared to baseline values taken at the original scan time or noted in the medical record based on a sum of clinical findings. Progression is defined as a ≥30% increase; Response is defined as a ≥30% decrease; and Stable disease is defined as a \<30% increase or decrease.
- groups
- description
- Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys
- id
- OG000
- title
- All Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- No echocardiographic data was available from the baseline imaging session with which to compare changes in the quantitative uptake and there was no contemporaneous echocardiography data in the medical record contemporaneous with baseline imaging
- reporting Status
- POSTED
- time Frame
- From enrollment to the end of the study is 8 days
- title
- Measure of Interest
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice