This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET/CT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET/CT will assess the diagnostic performance of 68Ga-NYM215 PET/CT at both the patient and lesion levels.
Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms that frequently overexpress somatostatin receptors (SSTRs), particularly SSTR subtype 2 (SSTR2), which provide specific targets for both imaging and therapy. As a somatostatin receptor agonist, 68Ga-DOTATATE PET/CT is an established imaging modality for the detection, staging, restaging, and treatment selection of patients with NETs. SSTR antagonists may show lower physiologic uptake in abdominal organs and have demonstrated potential for improved lesion detection compared with SSTR agonists. 68Ga-NYM215 is a novel SSTR antagonist with high receptor affinity. In preclinical SSTR-positive animal models, 68Ga-NYM215 demonstrated favorable safety, biodistribution, and tumor uptake.The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of 68Ga-NYM215 in patients with NETs. And compare the diagnostic ability of 68Ga-NYM215 with 68Ga-DOTATATE PET/CT. This prospective study will enroll patients with pathologically confirmed NENs. All participants will undergo both 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT. For radiation dosimetry, the first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference. Results were determined by two nuclear medicine physicians through consensus, with disagreements adjudicated through concurrent image interpretation involving a third senior physician. For each examination, lesions will be documented according to number, anatomical location, size, SUVmax, and tumor-to-background ratio (TBR). The study will explore the safety, biodistribution, radiation dosimetry, and diagnostic performance of 68Ga-NYM215 PET/CT. A head-to-head comparison with 68Ga-DOTATATE PET/CT will be performed to compare the diagnostic performance at both the patient and lesion levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
40 patients will be enrolled in this arm. Each patients will be injected with approximately 3mCi 68Ga-NYM215. The first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration.
Each patients will be injected with approximately 3mCi 68Ga-DOTATATE. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Diagnostic efficacy
Diagnostic efficacy of 68Ga-NYM215 PET/CT compared with 68Ga-DOTATATE PET/CT in the same participant, assessed on both a per-patient and per-lesion basis. Per-patient analysis will compare lesion detection rate. Per-lesion analysis will compare lesion detection rate, lesion number, size, SUVmax, and tumor-to-background ratio (TBR).
Time frame: At the time of paired PET/CT imaging, within 1 week.
Safety
Adverse effects after radiotracer injection.
Time frame: From radiotracer injection to 24 hours post-injection.
Biodistribution
The biodistribution of 68Ga-NYM215 will be evaluated in the following organs: pituitary gland, parotids, thyroids, lungs, blood pool, liver, spleen, pancreas (head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands.
Time frame: Through study completion, within 1 week.
Dosimetry
Absorbed dose for target organs, urinary bladder residence time, and whole-body effective dose were determined for 68Ga-NYM215.
Time frame: Through study completion, an average of 6 months.
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