A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer
This is a prospective, multicenter, open-label, single-arm, non-randomized Phase III clinical trial evaluating the diagnostic efficacy and safety of INR101 injection PET/CT imaging in detecting the presence of pelvic lymph node metastasis in participants who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. Participants enrolled in clinical trial will receive a single intravenous injection of INR101 injection at a dose of 7 mCi ± 15%, and PET/CT imaging will be performed 80 to 120 minutes after the injection. The PET/CT images of INR101 injection for each participant will be interpreted independently by two readers blinded to all participant information. When the conclusions of the two readers are inconsistent, a third reader will be added for an adjudication interpretation (the third reader will also be in a blinded during the interpretation process and shall not be aware of the conclusions of the first two readers).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
240
INR101
With the pathological diagnosis as the standard of truth, the sensitivity and specificity of INR101 injection PET/CT imaging in detecting pelvic lymph node metastasis at the participant level
The sensitivity and specificity of the participant-level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against histopathology
Time frame: 30 days after administration
With pathological diagnosis as the standard of truth, other diagnostic efficacies of INR101 injection PET/CT imaging in detecting pelvic lymph node metastasis at the participant level, including positive predictive value, negative predictive value and ac
The positive predictive value, negative predictive value and accuracy of the participant -level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against histopathology
Time frame: 30 days after administration
Compared with conventional imaging examinations, evaluate the difference in the detection rate of distant metastatic lesions (lymph nodes outside the pelvis, viscera/soft tissues and bones) by INR101 injection PET/CT imaging
The detection rate of distant metastatic lesions (lymph nodes outside the pelvis, viscera/soft tissues and bones) will be determined of INR101 injection PET/CT imaging for detection of lesion, comparing with conventional imaging
Time frame: 30 days after administration
Assess the consistency of the diagnosis of PET/CT images intra- and inter-reader
The intra- and inter-reader performance will be evaluated by adjudication rate and accept rate
Time frame: 30 days after administration
Evaluate the safety and tolerability, including adverse events (AE)/serious adverse events (SAE), vital signs, physical examinations, laboratory tests and 12-lead electrocardiograms
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Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Wuhan Central Hospital
Wuhan, Hubei, China
...and 22 more locations
Adverse events will be determined through clinical assessment and categorized by CTCAE 5.0
Time frame: 7 days after administration