Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Andrei Iagaru
With
National Cancer Institute (NCI)
OBJECTIVES:
1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.
2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy.
OUTLINE:
Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
After completion of study, patients are followed up at 24 to 48 hours.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Biopsy-proven prostate adenocarcinoma
Planned prostatectomy with lymph node dissection
Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\]
Diagnostic CT or MRI performed within 90 days of the research PET
Able to provide written consent
You may not be if
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
Metallic implants (contraindicated for MRI)
Clareo Health | 68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
