Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439914
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
Sponsor:
Nerissa T Viola
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
IFN-y PET Imaging Bench to Bedside
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 goal of this clinical trial is to investigate the use of 89ZrZr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer NSCLC patients PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy
Detailed Description:
Participants will be enrolled into the clinical trial once confirmed eligible Screening activities include standard of care blood work medical history and a physical exam
-Within 14 days of starting immunotherapy participants will complete PET scans 1-2 hours post-tracer administration again on the day following tracer administration and 3-5 days after the tracer administration This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans
-Within 14 days of starting immunotherapy participants will complete PET scans 1-2 hours post-tracer administration again on the day following tracer administration and 3-5 days after the tracer administration This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans
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?:
False
Is an FDA AA801 Violation?:
None