Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521775
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
An Investigational Scan Ga-68 PSMA-11 PETCT for the Detection of Therapy Response in Patients with Metastatic Adenoid Cystic Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study Evaluating PSMA PET for Metastatic Adenoid Cystic Carcinoma
Status:
ENROLLING_BY_INVITATION
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 phase II trial tests whether gallium-68 Ga-68 prostate specific membrane antigen PSMA-11 positron emission tomography PETcomputed tomography CT imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma salivary gland cancer that has spread from where it first started primary site to other places in the body metastatic The PET scan detects and takes pictures of where the radioactive imaging agent 68Ga PSMA-11 has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body Combining a PET scan with a CT scan can help make the images easier to interpret This study may help researchers learn whether GA-68 PSMA-11 PETCT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the feasibility of serial Ga-68 PSMA PETCT for response assessment in metastatic adenoid cystic carcinoma
II Assess the correlation of PSMA PETCT response assessment with serum extracellular vesical EV PSMA levels for patients undergoing treatment for metastatic adenoid cystic carcinoma
OUTLINE
Patients receive Ga-68 PSMA-11 intravenously IV and then undergo PETCT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy
After completion of study intervention patients are followed up at 1 day
I Evaluate the feasibility of serial Ga-68 PSMA PETCT for response assessment in metastatic adenoid cystic carcinoma
II Assess the correlation of PSMA PETCT response assessment with serum extracellular vesical EV PSMA levels for patients undergoing treatment for metastatic adenoid cystic carcinoma
OUTLINE
Patients receive Ga-68 PSMA-11 intravenously IV and then undergo PETCT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy
After completion of study intervention patients are followed up at 1 day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None