Phase 2 Study Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
研究概览
简要总结
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.
详细描述
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:
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Must have any of the following:
- •one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone
- •-ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
- •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 <=
- •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.
排除标准
- •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.
研究组 & 干预措施
1/[68Ga]Ga-PentixaFor PET/CT or PET/MR
Participants will undergo [68Ga]Ga-PentixaFor PET/CT or PET/MR
干预措施: [68Ga]Ga-PentixaFor (Drug)
结局指标
主要结局
Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
时间窗: Screening
The percent concordance between \[68Ga\]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals.
次要结局
- Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)(Within 1 year following [68Ga]Ga-PentixaFor imaging)
- Estimate the safety of [68Ga]Ga-PentixaFor(Day of [68Ga]Ga-PentixaFor administration until end of study participation)
- Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction(Within 1 year following [68Ga]Ga-PentixaFor imaging)