Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer
1 other identifier
interventional
100
1 country
1
Brief Summary
18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jul 2021
Shorter than P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedMay 3, 2023
May 1, 2023
1.8 years
April 12, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Time-activity curves
During the early dynamic Al18F-PSMA-617 PET imaging, the SUVmax of PCa lesions, the SUVmean of the normal tissues such as the prostate gland , the common iliac artery , the bladder, and the gluteus maximus were measured.Time-activity curves(TACs) describing SUVmax versus time of tumor lesion and areas with physiologic tracer uptake were generated.
through study completion, an average of 1 year
Kinetic parameters
Based on dynamic Al18F-PSMA-617 PET imaging, tracer kinetics(k1,k2,k3,k4,ki ) in tumor and normal tissues were generated by means of a two-tissue irreversible compartment model and Patlak graphical analysis.
through study completion, an average of 1 year
Differences in lesion detection at different imaging time point
In addition to the early dynamic images, we also performed whole-body delayed imaging at 2h and 4h after injection of Al18F-PSMA-617.The differences in lesion detectability at different time point were compared in order to determine the optimal imaging time.
through study completion, an average of 1 year
Diagnostic value
Sensitivity and Specificity of Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617
hrough study completion, an average of 1 year
Secondary Outcomes (1)
SUVmax of tumor
through study completion, an average of 1 year
Study Arms (1)
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
EXPERIMENTALPatients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/CT scan after intravenous administration of 68Ga-PSMA617 and Al18F-PSMA-617, respectively.
Interventions
Intravenous injection of one dosage of 0.1mCi/kg Al18F-PSMA-617. Tracer doses of Al18F-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.
Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.
Eligibility Criteria
You may qualify if:
- confirmed untreated prostate cancer patients;
- Ga-PSMA617 and Al18F-PSMA-617 PET/CT within two consecutive days;
- signed written consent.
You may not qualify if:
- known allergy against PSMA; • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Huo, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2023
First Posted
May 3, 2023
Study Start
July 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
May 3, 2023
Record last verified: 2023-05