Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cholangiocarcinoma
- Endometrial Cancer
- Esophageal Adenocarcinoma
- Esophagus SCC
- Urothelial/Bladder Cancer, Nos
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: This is a two step, open-label, basket trial looking at 5 different tumour types.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In various solid tumour types FDG-PET/CT has been shown to identify treatment-refractory diseases with a high negative predictive value (NPV) through a whole-body quantitative assessment of treatment-induced changes in tumour glucose uptake soon after treatment initiation, before any structural chan...
In various solid tumour types FDG-PET/CT has been shown to identify treatment-refractory diseases with a high negative predictive value (NPV) through a whole-body quantitative assessment of treatment-induced changes in tumour glucose uptake soon after treatment initiation, before any structural changes are observed. Progress in the standardisation of FDG-PET/CT imaging and response analysis now allow its use in multicentric trials opening the possibilities for trials where treatment allocation will be based on early metabolic response. MiMe has been built on the assumption that a medication which does not induce any metabolic changes in a given clinical setting is unlikely to induce a significant benefit and does consequently not deserve further investigation as a single agent in this setting. MiMe, by assessing metabolic response early during the treatment course, will hopefully provide useful information about the drug activity in various cancer types, and about mechanisms of resistance through a potential ambitious translational research program with serial collection of circulating-tumour DNA (ct-DNA).
Tracking Information
- NCT #
- NCT03339843
- Collaborators
- Eli Lilly and Company
- Investigators
- Study Chair: Laura Polastro, MD Jules Bordet Institute
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