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.
Additional locations may be listed on ClinicalTrials.gov for NCT06246357.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
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).
Lead OrganizationNational Cancer Institute
Principal InvestigatorM. Liza Lindenberg
