Trial Title:
11C-Metomidate PET/CT for Endocrine Hypertension and Characterisation of Adrenal Tumours
NCT ID:
NCT06100367
Condition:
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism
Adrenal Tumors
Conditions: Official terms:
Adenoma
Adrenal Gland Neoplasms
Hypertension
Hyperaldosteronism
Metomidate
Conditions: Keywords:
11-C Metomidate PET/CT
Functional imaging
Secondary / Endocrine hypertension
Adrenal Vein Sampling
Subtyping; localization testing
Adrenalectomy
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
Description:
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
Arm group label:
11C-metomidate PET-CT
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 (ClinicalTrials.gov 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 (e.g. 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For patients with primary aldosteronism (PA_CURE 2 / PA_MTO EH):
1. Confirmed diagnosis of primary aldosteronism, as defined in Endocrine Society
Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone
>140pmol/L); or hypokalemia with undetectable renin levels and aldosterone
>550pmol/L; or likely primary aldosteronism / low-renin hypertension
(inappropriate aldosterone levels and suppressed renin levels)
2. Keen for surgical treatment if shown to have unilateral adrenal disease.
- For patients with suspected adrenal tumors (PA_MTO AT)
1. All patients with suspected adrenal tumors based on imaging and clinical
suspicion.
Exclusion Criteria:
- Inability to provide written informed consent.
- Chronic renal failure of Stage 3b or greater severity, estimated glomerular
filtration rate (eGFR) < 45ml/min/1.73m2 using Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) formula. (only applicable for PA_CURE 2 / PA_MTO EH)
- Severe or terminal medical condition(s) that in the view of the investigator
prohibits participation in the study or interferes with possible treatment or
health-related quality of life, e.g. cancer, end-stage liver disease, end stage
renal failure (only applicable for PA_CURE 2 / PA_MTO EH)
- Contraindications to isotope scanning (e.g. Female patients who are pregnant
(self-declared or via positive pregnancy test), intending to become pregnant (within
3 months of scan) or breastfeeding) or CT Scan, which includes but not limited to
waist circumference >140cm, morbid obesity or claustrophobia (limiting entry in CT
scanner)
- Contraindication to ingestion of corticosteroids (e.g. poorly controlled diabetes,
HbA1C >13%)
Gender:
All
Minimum age:
21 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changi General Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Troy Puar Hai Kiat
Phone:
64267818
Email:
troy.puar.h.k@singhealth.com.sg
Facility:
Name:
Khoo Teck Puat Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Daphne Lee Hui Min
Phone:
65558000
Email:
lee.daphne.hm@ktph.com.sg
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Prof Roger Foo
Phone:
67723381
Email:
roger.foo@nus.edu.sg
Facility:
Name:
Ng Teng Fong General Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Yee Szemen
Phone:
67162000
Email:
yee_szemen@nuhs.edu.sg
Facility:
Name:
Sengkang General Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Chuah Bingfeng Matthew
Phone:
64267282
Email:
matthew.chuah@singhealth.com.sg
Facility:
Name:
Singapore General Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Swee Du Soon
Phone:
62223322
Email:
swee.du.soon@singhealth.com.sg
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Alvin Tan Wai Kit
Phone:
62566011
Email:
alvin_tan@ttsh.com.sg
Start date:
December 30, 2019
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Changi General Hospital
Agency class:
Other
Collaborator:
Agency:
National University Health System, Singapore
Agency class:
Other
Collaborator:
Agency:
Clinical Imaging Research Centre
Agency class:
Other
Collaborator:
Agency:
Singapore General Hospital
Agency class:
Other
Collaborator:
Agency:
Tan Tock Seng Hospital
Agency class:
Other
Collaborator:
Agency:
Khoo Teck Puat Hospital
Agency class:
Other
Collaborator:
Agency:
Ng Teng Fong General Hospital
Agency class:
Other
Collaborator:
Agency:
Sengkang General Hospital
Agency class:
Other
Source:
Changi General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06100367
