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NCT06246357 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
A Phase 2 study of Cushing's Syndrome and Hyperaldosteronism, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06246357: Recruiting Phase 2 study of Cushing's Syndrome and Hyperaldosteronism, sponsored by National Cancer Institute (NCI).
NCT06246357 is a Phase 2 study of Cushing's Syndrome and Hyperaldosteronism that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 752-participant average among 5 other Cushing's Syndrome trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06246357, a Phase 2 study of Cushing's Syndrome and Hyperaldosteronism, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The percent concordance between \[68Ga\]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals.
Conditions Studied
Interventions
- DRUG [68Ga]Ga-PentixaFor
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
What NCT06246357 shows while recruiting
NCT06246357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 752-participant average among 5 other Cushing's Syndrome trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Cushing's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which [68Ga]Ga-PentixaFor is the first listed.
NCT06246357 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06246357 about?
NCT06246357 is a clinical study titled "Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism". 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...
What is the current status of trial NCT06246357?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-09-23. Estimated completion is 2028-04-01.
What conditions does trial NCT06246357 study?
This clinical trial studies the following conditions: Cushing's Syndrome, Hyperaldosteronism, Hypercortisolism.
What interventions are being tested in trial NCT06246357?
The interventions under investigation include: [68Ga]Ga-PentixaFor (DRUG).
Who is sponsoring clinical trial NCT06246357?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06246357 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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