Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444412
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-31
Brief Title:
An Investigational Scan Ga-68 PSMA-11 PETCT for Detection of Disease Recurrence or Progression in Patients with Glioma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
GA-68 PSMA-11 PET to Evaluate Malignant Glioma Recurrence - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates whether gallium-68 Ga-68 prostate specific membrane antigen PSMA-11 positron emission tomography PETcomputed tomography CT imaging is useful in differentiating between disease that has come back after a period of improvement recurrence or that is growing spreading or getting worse progression and treatment effect in patients with glioma Patients with glioma undergo frequent imaging for assessment of disease status After first-line treatment however the correlation between imaging findings and tumor activity can be confused and surgery is often required for definitive diagnosis The PETCT scanner is an imaging machine that combines 2 types of imaging in a single scan The PET scanner detects and takes pictures of where the radioactive imaging agent 68Ga PSMA-11 has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body PSMA PET also binds to neoplastic blood vessels including those in gliomas This study may help researchers learn whether GA-68 PSMA-11 PETCT is useful for improving detection of tumor recurrence or progression as opposed to treatment effects in patients with gliomas
Detailed Description:
PRIMARY OBJECTIVE
I To assess uptake of Ga-68 labeled PSMA-11 in regions of high tumor cell density tumor recurrence and low tumor cell densitytreatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression versus vs in radiation treatment effects
SECONDARY OBJECTIVE
I To evaluate the immediate safety and tolerability of PSMA PET in patients with glioma
EXPLORATORY OBJECTIVES
I To identify optimal maximum standardized uptake value SUVmax thresholds for differentiating viable tumor from treatment effect
II To perform a radiology-pathology correlation of PSMA uptake at PET with tumor PSMA immunohistochemistry IHC immunostaining tumor pathology features and signal and enhancement characteristics at magnetic resonance imaging MRI no research MRI will be obtained based on MRI images obtained for clinical use
III To evaluate the added diagnostic value of gallium Ga 68 Ga-68 PSMA-11 PET beyond MRI using information from a clinical MRIs obtained prior to enrollment in the study for detecting viable enhancing tumor from treatment effects
OUTLINE
Patients receive Ga-68 PSMA-11 intravenously IV and then undergo PETCT over 1 hour 50-100 minutes after injection
I To assess uptake of Ga-68 labeled PSMA-11 in regions of high tumor cell density tumor recurrence and low tumor cell densitytreatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression versus vs in radiation treatment effects
SECONDARY OBJECTIVE
I To evaluate the immediate safety and tolerability of PSMA PET in patients with glioma
EXPLORATORY OBJECTIVES
I To identify optimal maximum standardized uptake value SUVmax thresholds for differentiating viable tumor from treatment effect
II To perform a radiology-pathology correlation of PSMA uptake at PET with tumor PSMA immunohistochemistry IHC immunostaining tumor pathology features and signal and enhancement characteristics at magnetic resonance imaging MRI no research MRI will be obtained based on MRI images obtained for clinical use
III To evaluate the added diagnostic value of gallium Ga 68 Ga-68 PSMA-11 PET beyond MRI using information from a clinical MRIs obtained prior to enrollment in the study for detecting viable enhancing tumor from treatment effects
OUTLINE
Patients receive Ga-68 PSMA-11 intravenously IV and then undergo PETCT over 1 hour 50-100 minutes after injection
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 |
|---|---|---|---|
| 23-007985 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2024-03913 | REGISTRY | None | None |