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Trial Title:
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
NCT ID:
NCT05841992
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Al18F-PSMA-617
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.
Arm group label:
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
Other name:
Al18F-PSMA-617 injection
Intervention type:
Drug
Intervention name:
68Ga-PSMA-617
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.
Arm group label:
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan
Other name:
68Ga-PSMA-617 injection
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Huo, MD
Phone:
13910801986
Email:
huoli@pumch.cn
Contact backup:
Last name:
Guilan Hu, MD
Phone:
86-18701023071
Email:
herb515@sina.com
Start date:
July 1, 2021
Completion date:
May 1, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841992
