Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478875
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-17
Brief Title:
Evaluation of 68GaGa-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pilot Study for the Evaluation of 68GaGa-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENTALON
Brief Summary:
PentixaFor radiolabeled with 68Gallium 68Ga is a radiopharmaceutical targeting the CXC chemokine receptor 4 CXCR4 receptor The CXCR4 receptor is expressed in zona glomerulosa of the adrenal cortex and in aldosterone producing adenoma APA The objective of this study will be to evaluate in 25 patients if 68GaGa-PentixaFor positron emission tomography 68GaGa-PTF-PET imaging allows for the discrimination of patients with lateralized or non-lateralized secretion of aldosterone in adrenal glands classified based on adrenal vein sampling AVS
Detailed Description:
The identification of the cause of primary aldosteronism PA is critical because in case of lateralized secretion of aldosterone a surgical treatment can be offered to patients with the objective of full patient recovery whereas in case of bilateral secretion only a long-term medical treatment with mineralocorticoid receptor antagonists should be considered The presence or absence of adrenal nodule on morphological imaging does not allow us to state on the lateralization or not of aldosterone secretion Moreover on one hand the prevalence of adrenal incidentalomas mostly non-secreting can be detected in between 2 to 10 of general population On the other hand unilateral secretion of aldosterone exists in 30 of patients with normal adrenal glands on imaging The AVS with measurements of the concentrations of aldosterone is the closest to a referral exam to confirm the diagnosis of lateralized secretion of aldosterone but it is a complex and invasive procedure with only limited access to centers with expertise in invasive radiology and an important heterogeneity in interpretation The development of noninvasive imaging approaches allowing for a more specific identification of lateralized vs bilateral aldosterone secretion would hence have a major impact on the clinical management of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505507-22-00 | OTHER | None | None |