Trial Title:
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients with Metastatic Adenoid Cystic Carcinoma
NCT ID:
NCT06521775
Condition:
Metastatic Adenoid Cystic Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Adenoid Cystic
Edetic Acid
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Intervention type:
Drug
Intervention name:
Ga-68 PSMA-11
Description:
Given IV
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
Other name:
68Ga-DKFZ-PSMA-11
Other name:
68Ga-HBED-CC-PSMA
Other name:
68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
68Ga-PSMA
Other name:
68Ga-PSMA-11
Other name:
68Ga-PSMA-HBED-CC
Other name:
[68Ga] Prostate-specific Membrane Antigen 11
Other name:
[68Ga]GaPSMA-11
Other name:
AAA 517
Other name:
AAA-517
Other name:
AAA517
Other name:
Ga PSMA
Other name:
Ga-68 labeled DKFZ-PSMA-11
Other name:
Ga-68 labeled PSMA-11
Other name:
Gallium Ga 68 PSMA-11
Other name:
Gallium Ga 68-labeled PSMA-11
Other name:
GALLIUM GA-68 GOZETOTIDE
Other name:
Gallium-68 PSMA
Other name:
Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
GaPSMA
Other name:
PSMA-HBED-CC GA-68
Other name:
Gallium Ga 68 Gozetotide
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Ga-68 PSMA-11, PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen
(PSMA)-11 positron emission tomography (PET)/computed 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 PET/CT 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 PET/CT for response assessment in
metastatic adenoid cystic carcinoma.
II. Assess the correlation of PSMA PET/CT 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 PET/CT 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥ 18 years of age
- Diagnosis of metastatic adenoid cystic carcinoma
- Enrolled in protocol MC200708
- Ability to tolerate a Ga68 PSMA PET/CT imaging study
- Willingness to return for a second PSMA PET/CT scan in approximately 12-20 weeks
from the baseline PET/CT
- Ability to give appropriate consent or have an appropriate representative available
to do so
Exclusion Criteria:
- Unable to undergo PET/CT scan
- Not a participant in MC200708
- < 18 years of age
- Persons who are pregnant or nursing
- Persons unable to consent to the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
August 12, 2024
Completion date:
August 12, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521775
https://www.mayo.edu/research/clinical-trials
