Al18F-NOTA-LM3: 40 patients will be enrolled in this arm. The first enrolled 8 patients will undergo serial whole-body PET/CT scans at multiple time points (5, 15, 30, 45, 60, and 120 min) after injection of Al18F-NOTA-LM3. The following patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.
68Ga-DOTATATE: All patients in arm A will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.
Al18F-NOTA-LM3: 40 patients will be enrolled in this arm. All patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.
68Ga-NODAGA-LM3: All patients in arm B will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-NODAGA-LM3. 68Ga-NODAGA-LM3 PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.
Study summary
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients aged 18 to 80 years.
* Histologically proven, well-differentiated, NETs (G1 or G2).
* No long-acting somatostatin analog treatment within 4 weeks.
* No PRRT treatment within 8 weeks.
Exclusion Criteria:
* Combined with other types of tumors.
* Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR\<30ml/min).
* Active infection.
* Pregnant or breast-feeding women.
* Inability to perform PET/CT scans.
Primary outcome measure(s)
Safety of Al18F-NOTA-LM3 — From radiotracer injection to 24 hours post-injection. Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Detection rate of Al18F-NOTA-LM3 on per-patient basis — From study completion to 6 months after completion. Percentage of patients with lesions detected on Al18F-NOTA-LM3 PET/CT.
SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT — From study completion to 6 months after completion. The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Detection rate of 68Ga-DOTATATE on per-patient basis — From study completion to 6 months after completion. Percentage of patients with lesions detected on 68Ga-DOTATATE PET/CT.
SUVmax of lesions detected on 68Ga-DOTATATE PET/CT — From study completion to 6 months after completion. The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Detection rate of 68Ga-NODAGA-LM3 on per-patient basis — From study completion to 6 months after completion. Percentage of patients with lesions detected on 68Ga-NODAGA-LM3 PET/CT.
SUVmax of lesions detected on 68Ga-NODAGA-LM3 PET/CT — From study completion to 6 months after completion. The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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