TriangleNCT00028002 · OUTCOME
FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage change in SUVmax
- Interval / dispersion
- Full Range
- Time frame
- change from baseline to 1 week post therapy
What was measured
evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
Groups in this outcome
PET Patricipants
FDG-PET was done at baseline, 1-7 days after IM initiation, in patients with GIST undergoing neoadjuvant IM therapy. Tumor GLUT4 expression by immunohistochemistry (IHC) and mutation analyses were done at baseline and/or surgery. Background-subtracted SUVmax was measured in all lesions and summed; Metabolic Response (MR)based on EORTC criteria was compared to Response Evaluation Criteria in Solid Tumors (RECIST), GLUT4 expression, and KIT/PDGFRA mutation status.
| Group | Source count |
|---|---|
| PET Patricipants | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PET Patricipants | -59.4 | Not reported | -100 | 81.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -100
- upper Limit
- 81.4
- value
- -59.4
- denoms
- counts
- group Id
- OG000
- value
- 44
- units
- Participants
- description
- evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
- dispersion Type
- Full Range
- groups
- description
- FDG-PET was done at baseline, 1-7 days after IM initiation, in patients with GIST undergoing neoadjuvant IM therapy. Tumor GLUT4 expression by immunohistochemistry (IHC) and mutation analyses were done at baseline and/or surgery. Background-subtracted SUVmax was measured in all lesions and summed; Metabolic Response (MR)based on EORTC criteria was compared to Response Evaluation Criteria in Solid Tumors (RECIST), GLUT4 expression, and KIT/PDGFRA mutation status.
- id
- OG000
- title
- PET Patricipants
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- change from baseline to 1 week post therapy
- title
- FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
- type
- SECONDARY
- unit Of Measure
- percentage change in SUVmax
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice