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| ID | Type | Description | Link |
|---|---|---|---|
| PA_MTO | Other Grant/Funding Number | Changi General Hospital |
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| Name | Class |
|---|---|
| National University Health System, Singapore | OTHER |
| Clinical Imaging Research Centre | UNKNOWN |
| Singapore General Hospital | OTHER |
| Tan Tock Seng Hospital |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11C-metomidate PET-CT | Experimental | All patients will undergo standard-of-care investigations (CT imaging of adrenals and AVS) and the research test (11C-metomidate PET-CT) with a dose of 100 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre | Combination Product | 11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH study). | The number of patients with complete, partial, and absent biochemical success according to the PASO criteria. | 6 months |
| Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral adrenocortical tumor (PA_MTO AT study). | Percentage of patients accurately identified with adrenocortical tumor using 11C-Metomidate PET-CT, when compared to the histopathology of the excised tumor. In patients who have not undergone surgery, this will be determined by clinical diagnosis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome of unilateral primary aldosteronism based on the Primary Aldosteronism Surgical Outcome (PASO) criteria (PA_CURE 2 / PA_MTO EH STUDY). | The number of patients with complete, partial, and absent clinical success according to the PASO criteria. | 6 months |
| Diagnostic performance of 11C-Metomidate PET-CT in identifying unilateral aldosterone-producing adenoma (PA_CURE 2 / PA_MTO EH study). |
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Inclusion Criteria:
For patients with primary aldosteronism (PA_CURE 2 / PA_MTO EH):
For patients with suspected adrenal tumors (PA_MTO AT)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore | ||||
| Khoo Teck Puat Hospital |
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| OTHER |
| Khoo Teck Puat Hospital | OTHER |
| Ng Teng Fong General Hospital | OTHER |
| Sengkang General Hospital | OTHER |
11C-metomidate synthesis will be done at Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.
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Percentage of patients accurately identified with unilateral PA using 11C-Metomidate PET-CT and AVS, as compared to histopathology of the excised tumor (defined as 'Classical' single, functioning aldosterone-producing adenoma using HISTopathological classification by the Histopathology of primary ALDOsteronism (HISTALDO) consensus). |
| 6 months |
| Cost-effectiveness of 11C-Metomidate PET-CT versus AVS in diagnosing patients with unilateral primary aldosteronism (PA_CURE 2 / PA_MTO EH STUDY). | Cost-effectiveness of the diagnostic course will be calculated by using calculated costs per quality-adjusted life years (QALYs). | 6 months |
| Diagnostic criteria using 11C-metomidate PET/CT (PA_CURE 2 / PA_MTO EH study). | The cut-off level of maximum standard update value (SUVmax) values which offer the best sensitivity and specificity for lateralization of aldosterone-producing adenoma in 11C-metomidate PET/CT. | 6 months |
| Number of patients with low-renin hypertension with unilateral adrenal tumors (PA_CURE 2 / PA_MTO EH study). | Quantify the number of patients with low-renin hypertension or only obtain borderline diagnostic criteria for PA but have unilateral adrenal lesions detected on 11C-metomidate PET/CT. | 6 months |
| Singapore |
| Singapore |
| National University Hospital | Singapore | Singapore |
| Ng Teng Fong General Hospital | Singapore | Singapore |
| Sengkang General Hospital | Singapore | Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Tan Tock Seng Hospital | Singapore | Singapore |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D000310 | Adrenal Gland Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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