Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189898
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Brief Title:
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Sponsor:
Sebastian Zschaeck
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRASE
Brief Summary:
This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation CRT sensitive squamous cell carcinomas of the esophagus SCEC at the end of preoperative or definitive CRT
Detailed Description:
This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation CRT sensitive squamous cell carcinomas of the esophagus SCEC at the end of preoperative or definitive CRT Successful validation of this biomarker could lead to a more individualized approach for patients ie organ preservation in highly chemoradiosensitive patients Since favorable response to CRT is associated with better outcome of patients the primary endpoint of the study is an improved event-free-survival EFS in responders receiving definitive CRT compared to non-responders Additional quality of life and other important endpoints side effects overall survival local control occurrence of distant metastases will be assessed in both treatment groups
The investigated PET parameters are Maximum standardized uptake ratio SURmax of the primary tumor at week four of chemoradiation and change of maximum standardized uptake value of the non tumor affected esophagus DeltaNTO
To improve the treatment in non-responders in future trials the study has two additional scientific support programmes included Genetic sequencing of tumor tissue to identify targetable mutations and correlate these with novel imaging biomarkers of none-response on the one hand biology based treatment optimization On the other hand the study will include an additional observational study arm In this arm patients with adenocarcinoma of the esophagus can be included Our biomarker has only been established in squamous cell carcinomas therefore it is an interesting exploratory question if the parameter can also be applied to patients with adenocarcinomas of the esophagus An additional scientific support program will establish primary tumor cells for better mechanistical understanding of the imaging biomarkers and testing of treatment according to targetable mutations
The investigated PET parameters are Maximum standardized uptake ratio SURmax of the primary tumor at week four of chemoradiation and change of maximum standardized uptake value of the non tumor affected esophagus DeltaNTO
To improve the treatment in non-responders in future trials the study has two additional scientific support programmes included Genetic sequencing of tumor tissue to identify targetable mutations and correlate these with novel imaging biomarkers of none-response on the one hand biology based treatment optimization On the other hand the study will include an additional observational study arm In this arm patients with adenocarcinoma of the esophagus can be included Our biomarker has only been established in squamous cell carcinomas therefore it is an interesting exploratory question if the parameter can also be applied to patients with adenocarcinomas of the esophagus An additional scientific support program will establish primary tumor cells for better mechanistical understanding of the imaging biomarkers and testing of treatment according to targetable mutations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None