Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
- Conditions
- HyperaldosteronismHypercortisolismCushing s Syndrome
- Interventions
- Registration Number
- NCT06246357
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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.
- Detailed Description
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 either of the following:
* one or more adrenal masses on CT and/or MRI with biochemical evidence of excess aldosterone or ACTH-independent hypercortisolism, 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 1 year until samples are obtained for correlative analysis from the parent protocol (adrenal venous sampling, imaging assessments, laboratory evaluations, and/or tissue samples).
* To account for inevaluable participants, the accrual ceiling will be set to 77 maximum participants with the number of evaluable participants enrolled as follows: 20 for Cohort 1, 20 for Cohort 2, and 30 for Cohort 3.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1/[68Ga]Ga-PentixaFor PET/CT or PET/MR [68Ga]Ga-PentixaFor Participants will undergo \[68Ga\]Ga-PentixaFor PET/CT or PET/MR
- Primary Outcome Measures
Name Time Method Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism Screening The percent concordance between \[68Ga\]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals.
- Secondary Outcome Measures
Name Time Method 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 The Spearman rank correlation coefficient between \[68Ga\]Ga-PentixaFor PET parameters (SUVmax, SUVmean, TLU, TV) and CXCR4 expression as measured via immunohistochemistry will be estimated within each Cohort.
Estimate the safety of [68Ga]Ga-PentixaFor Day of [68Ga]Ga-PentixaFor administration until end of study participation Safety will be evaluated by determining the frequency of adverse events among participants and reporting the results, by maximum grade of event and type of toxicity noted.
Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction Within 1 year following [68Ga]Ga-PentixaFor imaging Receiver operating characteristic (ROC) curves of \[68Ga\]Ga-PentixaFor SUVmax in detecting adrenal mass hyperfunction will be constructed. The cutoff associated with the highest Youden index (sensitivity plus specificity) will be selected as the optimal threshold.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States