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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT
研究概览
简要总结
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.
详细描述
Somatostatin receptors (SSTR), especially SSTR subtype 2 (SSTR2), are highly expressed in well-differentiated neuroendocrine tumors (NETs). Radiolabeled somatostatin analogs, including 68Ga-DOTATATE, are widely used for NET imaging and play essential roles in primary tumor seeking, staging, as well as management. SSTR antagonists have recently emerged as another type of somatostatin analog and showed better performance than analogs. Our previous studies exhibited better diagnostic efficacy of 68Ga-DOTA-LM3, 68Ga-DOTA-JR11, and 68Ga-NODAGA-LM3 compared to 68Ga-DOTATATE, especially liver metastasis.
18F-labeled radiotracers have shown several advantages compared to 68Ga-labelled tracers, including increased cyclotron production, lower positron energy, and longer half-life when compared to 68Ga, theoretically to the benefit of image quality. The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compare the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management related to imaging will also be compared.
Patients with histologically confirmed well-differentiated neuroendocrine tumors (G1 and G2) will be recruited in this study. All patients will be randomized into two arms (A and B): Patients in arm A performed Al18F-NOTA-LM3 and 68Ga-DOTATATE. Patients in arm B performed Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3. The first eight patients will undergo serial PET scans at 5, 15, 30, 45, 60, and 120 min after injection of Al18F-NOTA-LM3. The following patients will perform a whole-body PET/CT scan at 60-90 minutes after injection of Al18F-NOTA-LM3. All patients a whole-body PET/CT scan at 40-60 minutes after administering 68Ga-DOTATATE or 68Ga-NODAGA-LM3. For each patient, the two pet scans should be done within a week and the interval between the two scans should be at least 24h in case of mutual interference.
The images were reviewed by 2 experienced nuclear medicine physicians who were masked to all patients' clinical information. The results were based on consensus, with any discrepant result resolved by a consensus image interpretation by a third senior physician.
The biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 will be explored. The diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT will be compared. We will also compare the clinical management using different imaging modalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The images of patients will be reviewed by 2 experienced nuclear medicine physicians and they will be masked to all patients' clinical information.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT
时间窗: 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
时间窗: 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-NODAGA-LM3 PET/CT
时间窗: 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.
Safety of Al18F-NOTA-LM3
时间窗: 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
时间窗: 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 68Ga-DOTATATE PET/CT
时间窗: 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
时间窗: From study completion to 6 months after completion.
Percentage of patients with lesions detected on 68Ga-NODAGA-LM3 PET/CT.
次要结局
- SUVmax of normal organs(From study completion to 6 months after completion.)
- Absorbed dose of target organs(From study completion to 6 months after completion.)