A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies (NET-COMPARE)
A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Research Project Manager
- 電話番号：7649 604-675-8000
- メール：MITclinicaltrials@bccancer.bc.ca
研究連絡先のバックアップ
- 名前：Administrative Research Manager
- 電話番号：2818 604-877-6000
- メール：MITclinicaltrials@bccancer.bc.ca
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z 4E6
- BC Cancer Vancouver
-
コンタクト：
- Pavithraa Ravi
- 電話番号：2818 6048776000
- メール：pavithraa.ravi@bccancer.bc.ca
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
説明
Inclusion Criteria:
- Age ≥18 years
- Patients referred for and meeting institutional criteria for a [68Ga]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).
Exclusion Criteria:
- Pregnant and breast-feeding patients.
- Patients unwilling or unable to undergo a second PET/CT.
- Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PET/CT Diagnostic Imaging
Each subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada. |
Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
時間枠：Periprocedural
|
To assess the non-inferiority of [18F]AmBF3TATE compared to the standard-of-care [68Ga]DOTATATE |
Periprocedural
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of patients in whom one or more target lesions are detected by the core readers.
時間枠：within 2 weeks of the scan
|
Number of patients in whom [18F]AmBF3TATE and [68Ga]DOTATATE detects disease. |
within 2 weeks of the scan
|
|
Standard Uptake Values (SUV) for lesions detected
時間枠：within 2 weeks of the scan
|
To assess uptake values (SUV) for tumour lesions (SUVmax, SUVpeak, tumour to background ratio for liver, blood, kidney and lung, contrast and signal to noise ratio). |
within 2 weeks of the scan
|
|
CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment
時間枠：within 2 weeks of the scan
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To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices |
within 2 weeks of the scan
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Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
時間枠：within 2 weeks of the scan
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To assess reader confidence and inter-rater agreement |
within 2 weeks of the scan
|
|
Frequency of adverse events (AE) and serious adverse events (SAE).
時間枠：Immediately post-scan
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To compare the safety of both tracers |
Immediately post-scan
|
協力者と研究者
捜査官
- 主任研究者：Ian Alberts, MBBS MD PhD FEBNM、BC Cancer
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H26-00640
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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