Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 8:42 AM
Study NCT ID:
NCT05035732
Status:
WITHDRAWN
Last Update Posted:
2024-01-18
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
0 participant accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
Detailed Description:
Primary Objective:
--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.
Secondary Objective:
--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
Exploratory Objective:
--To study correlation between SUVmax and ADCmean in the pelvic RRPC.
--To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard.
Secondary Objective:
--To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
Exploratory Objective:
--To study correlation between SUVmax and ADCmean in the pelvic RRPC.
Study Oversight
Has Oversight DMC:
False
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-2021-09407 | OTHER | NCI-CTRP Clinical Trials Registry | View |