BridgeMD
New treatment option for Hyperaldosteronism
Official title Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
ClinicalTrials.gov ID: NCT06246357
What this study is testing
What is [68Ga]Ga-PentixaFor?
[68Ga]Ga-PentixaFor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hyperaldosteronism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.