A Phase 1/2 interventional study of 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT in Neuroendocrine Neoplasms, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Diagnostic
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.
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will perform a 68Ga-NYM215 PET/CT as well as a 68Ga-DOTATATE PET/CT.
Diagnostic Test: 68Ga-NYM215 PET/CT · Diagnostic Test: 68Ga-DOTATATE PET/CT
30 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.
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.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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