A Phase 2/3 interventional study of Al18F-PSMA-617 and 68Ga-PSMA-617 in Prostate Cancer, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Peking Union Medical College Hospital · Phase 2/3, Interventional, and Diagnostic
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
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
confirmed untreated prostate cancer patients;
Exclusion Criteria:
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.
Drug: Al18F-PSMA-617 · Drug: 68Ga-PSMA-617
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.
Also known as: Al18F-PSMA-617 injection
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.
Also known as: 68Ga-PSMA-617 injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: hrough study completion, an average of 1 year
SUVmax of tumor
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College Hospital