Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100367
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-10-13
Brief Title:
11C-Metomidate PETCT for Endocrine Hypertension and Characterisation of Adrenal Tumours
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
11C-Metomidate PETCT for Endocrine Hypertension and Characterisation of Adrenal Tumours
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
10 of patients with hypertension potentially have the treatable condition - primary aldosteronism PA This is caused by either bilateral adrenal disease 40 managed with lifelong medications or unilateral disease 60 cured with laparoscopic surgery adrenalectomy Current diagnosis of PA includes a screening test with aldosterone-renin ratio followed by a confirmatory salt loading test in most patients to demonstrate unsuppressed aldosterone levels Of note some patients with suppressed aldosterone after confirmatory tests also termed low-renin hypertension may also have unilateral adrenal tumors
The difficulty with identifying curable unilateral disease is due to adrenal vein sampling AVS an invasive and technically-difficult procedure An alternative novel imaging 11C-Metomidate Positron emission tomography-computed tomography PET-CT can detect adrenal tumors which are over-producing aldosterone It is non-invasive non-operator-dependent and potentially may identify more patients with curable unilateral disease The results from our pilot study in 25 patients with confirmed PA ClinicalTrialsgov NCT03990701 PA_CURE showed that 11C-Metomidate PET-CT exhibited comparable performance to AVS in subtyping PA and this should be validated in a larger study
In addition 11C-Metomidate is also able to differentiate adrenocortical lesions in the adrenal gland from other lesions found in adrenal tissue such as adrenomedullary lesions eg pheochromocytoma
Hence the investigators hypothesize that 11C-metomidate PET-CT can accurately 1 identify patients with surgically curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism PA_CURE 2 PA_MTO EH study and 2 differentiate adrenocortical lesions from other lesions in patients with adrenal tumors PA_MTO AT study
The difficulty with identifying curable unilateral disease is due to adrenal vein sampling AVS an invasive and technically-difficult procedure An alternative novel imaging 11C-Metomidate Positron emission tomography-computed tomography PET-CT can detect adrenal tumors which are over-producing aldosterone It is non-invasive non-operator-dependent and potentially may identify more patients with curable unilateral disease The results from our pilot study in 25 patients with confirmed PA ClinicalTrialsgov NCT03990701 PA_CURE showed that 11C-Metomidate PET-CT exhibited comparable performance to AVS in subtyping PA and this should be validated in a larger study
In addition 11C-Metomidate is also able to differentiate adrenocortical lesions in the adrenal gland from other lesions found in adrenal tissue such as adrenomedullary lesions eg pheochromocytoma
Hence the investigators hypothesize that 11C-metomidate PET-CT can accurately 1 identify patients with surgically curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism PA_CURE 2 PA_MTO EH study and 2 differentiate adrenocortical lesions from other lesions in patients with adrenal tumors PA_MTO AT study
Detailed Description:
The investigators aim to recruit 100 patients with confirmed or likely primary aldosteronism to undergo conventional tests CT AVS and 11C-metomidate PET-CT
Results will be reviewed and discussed at a multidisciplinary meeting and patients with unilateral PA or adrenal tumor will be offered surgery Patients will be reviewed 6 months post-surgery
In a separate study the investigators will recruit 10 patients with adrenal tumors to differentiate adrenocortical lesions from other lesions in patients with adrenal tumors
Results will be reviewed and discussed at a multidisciplinary meeting and patients with unilateral PA or adrenal tumor will be offered surgery Patients will be reviewed 6 months post-surgery
In a separate study the investigators will recruit 10 patients with adrenal tumors to differentiate adrenocortical lesions from other lesions in patients with adrenal tumors
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 |
|---|---|---|---|
| PA_MTO | OTHER_GRANT | Changi General Hospital | None |