Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Al18F-PSMA-617
68Ga-PSMA-617
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: confirmed untreated prostate cancer patients; 68Ga-PSMA617 and Al18F-PSMA-617 PET/CT within two consecutive days; signed written consent. Exclusion Criteria: known allergy against PSMA; • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Diagnostic value
Sensitivity and Specificity of Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617
Secondary Outcome Measures
SUVmax of tumor
The tumor uptake on Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617 PET/CT
Full Information
NCT ID
NCT05841992
First Posted
April 12, 2023
Last Updated
May 2, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05841992
Brief Title
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
Official Title
Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
Prostate cancer (PC) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. Due to low levels of glycolysis in prostate cancer cell, the uses of 18F-FDG PET/CT to detect prostate cancer and its metastases are limited. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-617, PSMA-11 for 68Ga-labeling have been developed. 68Ga-PSMA PET/CT has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by CT, MRI and bone scan. Al18F-PSMA-617 is a novel radiopharmaceutical targeting PSMA. Liu T et.al had demonstrated that Al18F-PSMA-617 accumulates specifically in PSMA-positive tumors with high binding affinity and selectivity. The first in-human evaluation of Al18F-PSMA-617 in a small PCa sample size also confirmed the good detectability of tumor lesions. This pilot study was prospectively designed to evaluate the early dynamic distribution of Al18F-PSMA-617 compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Drug
Intervention Name(s)
Al18F-PSMA-617
Other Intervention Name(s)
Al18F-PSMA-617 injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-617
Other Intervention Name(s)
68Ga-PSMA-617 injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time-activity curves
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Kinetic parameters
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Differences in lesion detection at different imaging time point
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Diagnostic value
Description
Sensitivity and Specificity of Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617
Time Frame
hrough study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
SUVmax of tumor
Description
The tumor uptake on Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617 PET/CT
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed untreated prostate cancer patients;
68Ga-PSMA617 and Al18F-PSMA-617 PET/CT within two consecutive days;
signed written consent.
Exclusion Criteria:
known allergy against PSMA; • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, MD
Phone
86-13910801986
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guilan Hu, MD
Phone
86-18701023071
Email
herb515@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
Phone
13910801986
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name & Degree
Guilan Hu, MD
Phone
86-18701023071
Email
herb515@sina.com
12. IPD Sharing Statement
Learn more about this trial
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
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