Comparison of Al18F-NOTA-LM3 With 68Ga-DOTATATE and 68Ga-NODAGA-LM3 PET/CT in Patients With Well-differentiated Neuroendocrine Tumors
Evaluation of Biodistribution, Dosimetry, Diagnostic Ability, and Safety of Al18F-NOTA-LM3 in Patients With Well-differentiated Neuroendocrine Tumors, and Comparison With 68Ga-DOTATATE and 68Ga-NODAGA-LM3: A Prospective, Single-center, Double-blinded Study
Peking Union Medical College Hospital
80 participants
Mar 23, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
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.
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.
40 patients will be enrolled in this arm. All patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.
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.
Locations(1)
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NCT06056362