異所性クッシング症候群患者における 68Ga-DOTATATE PET/CT、オクトレオチドおよび F-DOPA PET イメージングの評価
Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard dose of indium- 111 pentetreotide ([111In-DTPA-D-Phe]-pentetreotide). The sensitivity and specificity of structurally based imaging studies depends on anatomic alterations and the size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand imaging detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests the ability of [18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET, and the somatostatin imaging analogue, 68Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.
調査の概要
状態
詳細な説明
Study Description:
Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard dose of indium- 111 pentetreotide ([111In-DTPA-D-Phe]-pentetreotide). The sensitivity and specificity of structurally based imaging studies depends on anatomic alterations and the size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand imaging detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue.
This protocol tests the ability of [18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET, and the somatostatin imaging analogue, 68Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.
Objectives:
Primary Objectives:
- To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, standard CT, and/or standard MRI) has the best sensitivity.
- To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
Secondary Objective:
-To evaluate a potential correlation between 18F-DOPA or 68Ga-DOTATATE uptake and the type of tumor, its size, SSTR expression or proliferative activity.
Exploratory Objectives:
- To evaluate the ability of gated cardiac imaging with CT and MRI to improve the detection of retrocardiac lung lesions.
- To determine whether PET scans at an interval of less than one year localize tumors.
Endpoints:
Primary Endpoint:
-Imaging results and pathology of resected tumors
Secondary Endpoints:
-18F-DOPA or 68Ga-DOTATATE imaging results, tumor pathology, tumor size, proliferative index and SSTR expression.
Exploratory Endpoints:
- Gated cardiac imaging CT and/or MRI; all other imaging results, tumor pathology.
- Imaging results and pathology of resected tumors.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Raven N McGlotten, R.N.
- 電話番号：(301) 827-0190
- メール：mcglottenr@mail.nih.gov
研究連絡先のバックアップ
- 名前：Lynnette K Nieman, M.D.
- 電話番号：(301) 496-8935
- メール：niemanl@mail.nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
-
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
説明
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all of the following criteria:
- 18 - 90 years of age
- Medical history of ectopic Cushing syndrome or diagnosed with the possibility of ectopic Cushing syndrome
- For females of reproductive potential: agreement to use highly effective contraception for at least 2 weeks before any PET scan
- Ability of subject to understand and the willingness to sign a written informed consent document
- Stated willingness to comply with all study procedures and availability for the duration of the study
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation; the radiation associated with PET and CT scans may be harmful to a developing fetus. Likewise the ingestion of radionuclides in breast milk has an unknown risk to an infant.
- Evidence of severe active infection
- Clinically significantly impaired cardiovascular function, abnormal coagulation in the absence of medically-indicated treatment (PT and PTT elevated by 30% above the normal values), hematopoietic (hematocrit less than 30%, hemoglobin below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm^3), hepatic (liver enzymes elevated by 4-fold above normal values), or renal function (plasma creatinine level over 2.1).
- Based on the clinical judgment of the attending physician, other medical problems may prompt exclusion.
- Body weight over 136 kg, which is the limit for the tables used in the scanning areas.
- Combined blood withdrawal during the six weeks preceding the study greater than 450 ml.
- Subjects who previously underwent ten or more F-DOPA PET/CT scans and ten or more DOTATATE scans.
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
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Imaging
All subjects will be imaged |
68Ga-DOTATATE PET/CT 68Ga-DOTATATE PET/CT routine CT scan routine 1.5 or 3T MRI scan Cardiac gated MRI scan 68Ga-DOTATATE radioligand 18F-DOPA radioligand |
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 |
|---|---|---|
|
To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.
時間枠：6-12 months
|
Subjects will be imaged every 6-12 months until tumor is found |
6-12 months
|
|
To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
時間枠：6-12 months
|
subjects will be imaged every 6-12 months until tumor is found |
6-12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
18F-DOPA または 68Ga-DOTATATE の取り込みと腫瘍の種類、そのサイズ、SSTR 発現、または増殖活性の間の潜在的な相関関係を評価します。
時間枠：進行中
|
進行中
|
協力者と研究者
捜査官
- 主任研究者：Lynnette K Nieman, M.D.、National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (推定)
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
- 140028
- 14-CH-0028
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?
IPD プランの説明
On request, IPD related to a publication will be made available.
IPD 共有時間枠
Start at the time of publication, for five years unless the study investigators leave NIH
IPD 共有アクセス基準
The PI will review requests and will provide data to investigators who wish to perform meta-analysis with other manuscript results. Data will be provided as an anonymized excel spread sheet.
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
- CSR
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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