Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199713
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-12-27
Brief Title:
Correlating Early FDG PETCT and ctDNA in Immune Checkpoint Inhibitor ICI-Treated Melanoma Patients
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission TomographyComputed Tomography PETCT and Circulating Tumor DNA ctDNA in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The purpose of this research study is to determine if analysis of PETCT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy
Detailed Description:
This is a pilot prospective observational study to estimate the degree to which baseline and early interval 18F-FDG PETCT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends predict clinical response onset of immune-related adverse events and survival outcomes in advanced stage melanoma patients
Primary Objective
To determine if early interval response assessment with 18F-FDG PETCT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients
Secondary Objectives
To determine if early interval response assessment with 18F-FDG PETCT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT predicts development of clinical irAEs in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT and ctDNA level predicts progression-free survival PFS in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT and ctDNA level predicts overall survival OS in advanced melanoma patients
Primary Objective
To determine if early interval response assessment with 18F-FDG PETCT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients
Secondary Objectives
To determine if early interval response assessment with 18F-FDG PETCT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT predicts development of clinical irAEs in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT and ctDNA level predicts progression-free survival PFS in advanced melanoma patients
To assess if early interval response assessment with 18F-FDG PETCT and ctDNA level predicts overall survival OS in advanced melanoma patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UW23077 | OTHER | None | None |
| A534260 | OTHER | None | None |
| Protocol Version 2122024 | OTHER | None | None |
| NCI-2023-11059 | REGISTRY | NCI Trial ID | None |