A Prospective, Open-label, Multi-center, Single Arm, Phase III Study of [68Ga]Ga-DOTA-TATE in the Diagnosis of Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 8
- 主要终点
- Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
研究概览
简要总结
The purpose of this study was to evaluate the diagnostic performance of [68Ga]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in patients with neuroendocrine neoplasms (NENs) and healthy volunteers (HVs).
The data from this study was collected in order to provide the evidence for diagnosis of [68Ga]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.
详细描述
A total of 71 participants (48 patients with confirmed/suspected NENs and 23 HVs) were enrolled to ensure that at least 70 participants (47 patients with confirmed/suspected NENs and 23 HVs) were evaluable for the co-primary endpoints. All enrolled participants were administered [68Ga]Ga-DOTA-TATE and PET/CT scan.
The co-primary endpoints of the subject-level sensitivity and the subject-level specificity were assessed by comparing the central reading results of the [68Ga]Ga-DOTA-TATE PET/CT scan to the central reading results of Conventional imaging (CIM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must have been obtained prior to participation in the study
- •Participants must have been adults >= 18 years of age
- •ECOG performance status 0-2
- •For patient with NENs only: Participants were to be confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization could not have been confirmed by CIM
- •For HVs only: Male or female participant in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, lab test and ECG
- •Women of childbearing potential must havehad a negative urine or blood pregnancy test.
排除标准
- •Inability to complete the needed investigational and conventional imaging due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
- •Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation
- •Known allergy, hypersensitivity, or intolerance to [68Ga]Ga-DOTA-TATE and [111In]In-Pentetreotide
- •Therapeutic use of any somatostatin analogue except for the following washout period
- •Short-acting analogs of somatostatin can be used up to 24 hours before injection of [68Ga]Ga-DOTA-TATE.
- •Long-acting analogs of somatostatin can be used up to 28 days before injection of [68Ga]Ga-DOTA-TATE.
- •Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-DOTA-TATE
- •Use of other investigational drugs within 30 days before screening
- •Participants who were pregnant.
- •Participants who were lactating.
研究组 & 干预措施
[68Ga]Ga-DOTA-TATE
All eligible participants will receive [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
干预措施: [68Ga]Ga-DOTA-TATE (Drug)
[68Ga]Ga-DOTA-TATE
All eligible participants will receive [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)
干预措施: 68Ge/68Ga Generator (Drug)
结局指标
主要结局
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
时间窗: Day 1
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). * TP participants were those who showed at least one lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FN participants were those who did not show any lesions based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants)
时间窗: Day 1
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). * TN participants were those who did not show any lesions based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FP participants were those who showed at least one lesion based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Subject-level Sensitivity
时间窗: Day 1
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Sensitivity = TP / (TP + FN)
Subject-level Specificity
时间窗: Day 1
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Specificity = TN / (TN + FP).
次要结局
- Number of Participants Who Are Positive on Both [68Ga]Ga-DOTA-TATE PET/CT Imagings and CIM (TP Participants) Among Participants Who Are Positive on [68Ga]Ga-DOTA TATE PET/CT Imaging (TP or FP Participants)(Day 1)
- Number of Participants Who Are Negative on Both [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM (TN Participants) Among Participants Who Are Negative on [68Ga]Ga-DOTA-TATE PET/CT Imaging (TN or FN Participants)(Day 1)
- Subject-level PPV(Day 1)
- Subject-level NPV(Day 1)
- Participants Who Have Consistent Results (i.e. TP or TN Participants) Among All Participants Assessed by [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM - Subject-level Accuracy(Day 1)
- Region-level Sensitivity(Day 1)
- Region-level Specificity(Day 1)
- Region-level Positive Predictive Values (PPV)(Day 1)
- Region-level Negative Predictive Values (NPV)(Day 1)
- Region-level Accuracy(Day 1)
- Region-level True Positive(Day 1)
- Region-level False Negative(Day 1)
- Region-level False Positive(Day 1)
- Region-level True Negative(Day 1)
- Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires(Before and after imaging on Day 1)
- Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging(Day 1)
- Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging(Day 1)
- Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration(For treated pts: AEs are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days. For HV pts: AEs are reported from the study start plus 8 days, up to a maximum timeframe of 9 days.)
- Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration](Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min))
- Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available(Day 1 to Day 30)
- Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available - Concordance Rate(Day 1 to Day 30)