Evaluating adrenal gland function using a new imaging agent in patients with hormone-related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of a new radioactive tracer, [68Ga]Ga-PentixaFor, in identifying functional adrenal tumors through positron emission tomography (PET) scans. The study will enroll participants aged 18 and older who have adrenal tumors and elevated hormone levels related to hyperaldosteronism or hypercortisolism. Participants will be categorized into three cohorts based on their specific adrenal conditions and will undergo imaging scans to evaluate the concordance of the new imaging agent with clinical diagnoses. The goal is to improve the identification of functional tumors, which is crucial for determining appropriate treatment options.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Maria Liza Lindenberg, M.D. — National Cancer Institute (NCI)
• Study coordinator: Yolanda L McKinney, R.N.
• Email: ymckinney@mail.nih.gov
• Phone: (240) 760-6095

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adrenal Diseases in Modena: A Patient Registry at Modena University Hospital

  This study collects medical histories and treatment data from patients with adrenal diseases to see how they are diagnosed and managed in Modena.

  Recruiting Azienda Ospedaliero-Universitaria di Modena · Modena, Modena · NCT07920198

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  This project will test whether REMS, a radiation-free ultrasound method, can measure bone mineral density in children and adolescents aged 5–18 who have conditions that weaken their bones.

  Recruiting Meyer Children's Hospital IRCCS · Florence, Tuscany · NCT07412782

• CXCR4-targeted PET/CT to find the source of Cushing's syndrome

  This trial will try 68Ga‑Pentixafor (CXCR4) PET/CT scans to help tell apart ACTH-dependent and ACTH-independent Cushing's syndrome and to locate the tumors causing the condition in people with suspected or confirmed Cushing's.

  Recruiting Phase 1/2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07350707

• Targeted adrenal artery embolization versus oral spironolactone for idiopathic hyperaldosteronism

  This trial will test whether a minimally invasive targeted adrenal artery embolization works as well as the oral drug spironolactone for people aged 15–60 with idiopathic hyperaldosteronism.

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• Aldosterone-hybrid test to guide curable treatment for primary aldosteronism

  This trial tests whether non-invasive biomarkers plus CT imaging can identify unilateral primary aldosteronism and reduce the need for adrenal vein sampling in patients considered for surgery.

  Recruiting at 4 sites Changi General Hospital · Singapore, Singapore and 5 other locations · NCT07297745

• Adrenal vein sampling in China

  This project tests whether different adrenal venous sampling techniques and AVS-guided management help people with primary aldosteronism get better long-term blood pressure and hormone results.

  Recruiting at 76 sites Chinese Academy of Medical Sciences, Fuwai Hospital · Hefei, Anhui and 75 other locations · NCT07252284

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.