- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05841992
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
May 2, 2023 updated by: Peking Union Medical College Hospital
Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li Huo, MD
- Phone Number: 86-13910801986
- Email: huoli@pumch.cn
Study Contact Backup
- Name: Guilan Hu, MD
- Phone Number: 86-18701023071
- Email: herb515@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Li Huo, MD
- Phone Number: 13910801986
- Email: huoli@pumch.cn
-
Contact:
- Guilan Hu, MD
- Phone Number: 86-18701023071
- Email: herb515@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-activity curves
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: hrough study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SUVmax of tumor
Time Frame: through study completion, an average of 1 year
|
The tumor uptake on Al18F-PSMA-617 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617 PET/CT
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li Huo, MD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
May 2, 2023
First Posted (Actual)
May 3, 2023
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUMCHFPSMA617
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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