A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in participants with suspected recurrent prostate cancer after radical treatment.
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 participants with suspected recurrence prostate cancer, who have experienced an increase in PSA levels after previously receiving radical treatment. 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). This study adopts a composite diagnostic criterion as the standard of truth. The interpretation of the composite diagnostic criterion is as follows: If a pathological diagnosis can be obtained, the pathological diagnosis shall be regarded as the standard of truth; if a pathological diagnosis cannot be obtained, a comprehensive interpretation shall be made based on the participant's medical history, changes in PSA levels and the results of conventional imaging examinations. The interpretation of the composite diagnostic criterion for each participant will be interpreted independently by two readers. When the conclusions of the two readers are inconsistent, a third reader will be added for an adjudication interpretation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
110
INR101 PET/ CT
With the composite diagnostic criteria as the standard of truth, the positive predictive value (PPV) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The positive predictive value (PPV) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
Time frame: 3~12 months after administration
With pathological diagnosis as the standard of truth, Correct Detection Rate (CDR), Correct Localization Rate (CLR) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The Correct Detection Rate (CDR), Correct Localization Rate (CLR) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
Time frame: 3~12 months after administration
With pathological diagnosis as the standard of truth, the positive predictive value (PPV) at the regional level (prostate, pelvic lymph nodes, extra-pelvic lymph nodes, visceral/soft tissues, bone) by PET/CT imaging with INR101 injection of lesion detect
The positive predictive value (PPV) of the regional level (prostate, pelvic lymph nodes, extra-pelvic lymph nodes, visceral/soft tissues, bone) will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
Time frame: 3~12 months after administration
In the group with negative baseline conventional imaging, the detection rate (DR), correct detection rate (CDR), and positive predictive value (PPV) at the participant level by PET/CT imaging with INR101 injection of lesion detection
The detection rate (DR), correct detection rate (CDR), and positive predictive value (PPV) of the participant level will be determined of INR101 injection PET/CT imaging for detection of lesion, confirming against imaging, clinical follow-up, and histopathology when available
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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
Time frame: 3~12 months after administration
Among participants with different baseline PSA levels, the positive predictive value (PPV) at the participant level of PET/CT imaging with INR101 injection
The positive predictive value (PPV) will be evaluated on a per- participant basis, stratified by PSA values: 0.2\~0.5, 0.5\~1.0, 1.0 \~2.0, 2.0\~5.0, ≥5.0ng/mL
Time frame: 3~12 months 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: 3~12 months 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
Adverse events will be determined through clinical assessment and categorized by CTCAE 5.0
Time frame: 7 days after administration