Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer.
Matthias Eiber, Gregor Weirich, Konstantin Holzapfel...
https://pubmed.ncbi.nlm.nih.gov/26795686Actively Recruiting
Age: 40Years - 85Years
MALE
Healthy Volunteers
ID06494696
Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Led by Chang Gung Memorial Hospital · Updated on 2024-07-10
71
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
N
National Science and Technology Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether Ga-68 PSMA PET/MRI can improve the diagnosis of prostate cancer compared to multiparametric MRI (mpMRI) in men aged 40 to 85 who have not had a prostate biopsy but show signs suspicious for prostate cancer. This observational study aims to determine if PSMA PET/MRI offers better positive and negative predictive values and how lesion location agreement between PET and MRI affects diagnostic accuracy. Participants will have a Ga-68 PSMA PET/MRI scan and then be monitored for two years to see if prostate cancer is diagnosed. During this period, they will visit the clinic every six months for checkups and blood tests. The study evaluates imaging results alongside clinical outcomes to assess diagnostic performance. Throughout the study, participants will undergo regular clinical assessments including blood tests every six months for two years. Researchers will measure how well the imaging techniques predict cancer presence using positive and negative predictive values based on lesion findings and PI-RADS scores. The follow-up visits and imaging aim to monitor participants’ health and gather data on prostate cancer diagnosis over time.
CONDITIONS
Brief Title
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Who Can Participate
Age: 40Years - 85Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male patients aged 40 to 85 years
- Clinical suspicion of prostate cancer based on elevated PSA (4 to 20 ng/mL), abnormal digital rectal exam, or lower urinary tract symptoms
- No prior prostate biopsy
- Daily physical status graded 0 to 2 according to ECOG criteria
- Willing to sign informed consent
- Life expectancy greater than two years
You will not qualify if you...
- Unable to tolerate PET/MRI scan due to claustrophobia, inability to lie still, unclear consciousness, unstable vital signs, or MRI-unsafe metal implants or devices
- Renal impairment with glomerular filtration rate below 30 ml/min/1.73 m2
- Allergy to contrast medium
- High risk for examination based on PI evaluations
- History of previous malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo a Ga-68 PSMA PET/MRI scan to evaluate prospective prostate cancer risk.
1 visit (in-person)
Long-term Monitoring
Duration - 2 years
Participants are followed up for 2 years to observe if prostate cancer is diagnosed after the PET/MRI scan.
Follow-up visits as needed over 2 years
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital ,Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
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Research Team
J
Jing-Ren Tseng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Mohammad Al-Bayati, Johannes Grueneisen, Susanne Lütje...
https://pubmed.ncbi.nlm.nih.gov/29393268Diagnostic Accuracy of Multiparametric MRI versus 68Ga-PSMA-11 PET/MRI for Extracapsular Extension and Seminal Vesicle Invasion in Patients with Prostate Cancer.
Urs J Muehlematter, Irene A Burger, Anton S Becker...
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Louise Emmett, James Buteau, Nathan Papa...
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Anthony Bates, Kenneth Miles
https://pubmed.ncbi.nlm.nih.gov/28608163Benign Prostatic Hyperplasia-Related False-Positive of Prostate-Specific Membrane Antigen-Positron Emission Tomography in the Diagnosis of Prostate Cancer: The Achilles' Heel of Biopsy-Free Radical Prostatectomy?
Wei Tang, Yongxiang Tang, Lin Qi...
https://pubmed.ncbi.nlm.nih.gov/37647549Investigating PSMA-PET/CT to resolve prostate MRI PIRADS4-5 and negative biopsy discordance.
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https://pubmed.ncbi.nlm.nih.gov/36602577