高アルドステロン症および高コルチゾール症における[68Ga]Ga-PentixaForによる副腎の機能状態の評価
高アルドステロン症および高コルチゾール症における[68Ga]Ga-ペンティキサフォルによる副腎の機能状態を評価する第2相研究
Background:
The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional.
Objective:
To see if a new radioactive tracer ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans.
Eligibility:
People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242).
Design:
Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed.
Participants will have one PET scan with the study tracer.
The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes.
Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan.
Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.
調査の概要
詳細な説明
Background:
- [68Ga]Ga-PentixaFor is a PET agent targeting the C-X-C chemokine receptor type 4 (CXCR4) with promising applications in oncology, cardiology, and infectious disease.
- CXCR4 has also been noted to show high expression in many aldosterone-producing adenomas (APA) and some cortisol-producing adenomas (CPA) but not usually in nonfunctioning adenomas.
- [68Ga]Ga-PentixaFor may be useful in the evaluation of adrenal adenomas in the setting of Conn's or Cushing's syndrome. Localizing functional adenomas is important for managing treatment options but current imaging modalities are either too invasive or insufficiently able to differentiate adrenal conditions.
Objective:
-To estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
Eligibility:
-
Must have any of the following:
- one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone or
- ACTH-independent hypercortisolism with or without adrenal masses on CT and/or MRI or
- history of ACTH-dependent hypercortisolism (with or without adrenal enlargement)
-
Age >= 18 years
-
ECOG performance status <= 2
Design:
- This is a Phase II, single site study where participants from three cohorts are enrolled into one arm according to their probable disease: primary aldosteronism (Cohort 1), ACTHindependent Cushing's syndrome (Cohort 2), or ACTH-dependent Cushing's syndrome (Cohort 3).
- All participants will undergo a [68Ga]Ga-PentixaFor PET/CT or [68Ga]Ga-PentixaFor PET/MR.
- A safety visit will be performed 3 days following the [68Ga]Ga-PentixaFor imaging.
- Participants will remain on-study for up to 1 year to allow the collection of samples for correlative analysis from the parent protocol (adrenal venous sampling, imaging assessments, laboratory evaluations, and/or tissue samples).
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：Maria Liza Lindenberg, M.D.
- 電話番号：(240) 760-6109
- メール：liza.lindenberg@mail.nih.gov
研究連絡先のバックアップ
- 名前：Yolanda L McKinney, R.N.
- 電話番号：(240) 760-6095
- メール：ymckinney@mail.nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- National Cancer Institute Referral Office
- 電話番号：888-624-1937
-
-
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:
-
Must have any of the following:
- one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone
OR
--ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
OR
-
history of ACTH-dependent hypercortisolism (with or without adrenal enlargement)
-
Co-enrollment in 19-DK-0066, 09-C-0242, 18-CH-0031 or a similar NIH trial.
-
Age >=18 years.
-
ECOG performance status <= 2.
-
Women of child-bearing potential (WOCBP) and men must agree to use an effective contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization, abstinence) for two weeks prior to [68Ga]Ga-PentixaFor scan and for one week after the [68Ga]Ga-PentixaFor scan.
- Breastfeeding should be discontinued for one week after the [68Ga]Ga-PentixaFor scan.
- Men must agree not to donate sperm for one week after the [68Ga]Ga-PentixaFor scan.
-
Participants must be able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA:
- Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
- Uncontrolled intercurrent illness or social situations based on the review of medical history that would limit compliance with study requirements.
- Contraindications to having an MRI and CT.
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：1/[68Ga]Ga-PentixaFor PET/CT or PET/MR
Participants will undergo [68Ga]Ga-PentixaFor PET/CT or PET/MR |
[68Ga]Ga-PentixaFor will be injected intravenously approximately 60 minutes prior to scanning at a dose of 150 +/- 50 MBq (4 mCi +/- 1.4). |
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 |
|---|---|---|
|
Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
時間枠：Screening
|
The percent concordance between [68Ga]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals. |
Screening
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)
時間枠：Within 1 year following [68Ga]Ga-PentixaFor imaging
|
The Spearman rank correlation coefficient between [68Ga]Ga-PentixaFor PET parameters (SUVmax, SUVmean, TLU, TV) and CXCR4 expression as measured via immunohistochemistry will be estimated within each Cohort. |
Within 1 year following [68Ga]Ga-PentixaFor imaging
|
|
Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction
時間枠：Within 1 year following [68Ga]Ga-PentixaFor imaging
|
Receiver operating characteristic (ROC) curves of [68Ga]Ga-PentixaFor SUVmax in detecting adrenal mass hyperfunction will be constructed. The cutoff associated with the highest Youden index (sensitivity plus specificity) will be selected as the optimal threshold. |
Within 1 year following [68Ga]Ga-PentixaFor imaging
|
|
Estimate the safety of [68Ga]Ga-PentixaFor
時間枠：Day of [68Ga]Ga-PentixaFor administration until end of study participation
|
Safety will be evaluated by determining the frequency of adverse events among participants and reporting the results, by maximum grade of event and type of toxicity noted. |
Day of [68Ga]Ga-PentixaFor administration until end of study participation
|
協力者と研究者
捜査官
- 主任研究者：Maria Liza Lindenberg, M.D.、National Cancer Institute (NCI)
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 (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
その他の研究ID番号
- 10001600
- 001600-C
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
All IPD recorded in the medical record will be shared with intramural investigators upon request.
IPD 共有時間枠
This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
IPD 共有アクセス基準
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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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