Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-01 @ 4:07 PM
Study NCT ID:
NCT06015295
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
Status:
RECRUITING
Status Verified Date:
2025-10
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:
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
Detailed Description:
Primary Objective:
* To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.
Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold standard truth divided by the total sample size.
Secondary Objectives
* To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
* To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with metastatic brain lesion(s).
* To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy.
Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold standard truth divided by the total sample size.
Secondary Objectives
* To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy by additional accuracy measures including sensitivity, specificity, negative predictive value and positive predictive value.
* To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with metastatic brain lesion(s).
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-09643 | OTHER | NCI-CTRP Clinical Trials Registry | View |