Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616142
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Subtyping Primary Aldosteronism with Para-chloro-2-18Ffluoroethyl-etomidate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Para-chloro-2-18Ffluoroethyl-etomidate 18FCETO As a New PET-tracer for Subtyping in Patients with Primary Aldosteronism - a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACE
Brief Summary:
The goal of this clinical trial is to investigate the uptake characteristics of 18FCETO in adrenal tissue in patients with two different subtypes of primary aldosteronism The main questions it aims to answer are
What are the uptake characteristics of 18FCETO in adrenal tissue in patients with primary aldosteronism
What is the concordance between the adrenal vein sampling and the 18FCETO PETCT scan results
What is the effect of adrenal perfusion on 18FCETO uptake in the adrenal glands
Researchers will compare the results of the adrenal vein sampling to a 18FCETO PETCT scan to see if the PETCT can accurately identify the subtypes of primary aldosteronism Participants will
Take dexamethasone three days prior to the scan
Undergo a 18FCETO PETCT
Report burden of pre-treatment and PETCT scan
What are the uptake characteristics of 18FCETO in adrenal tissue in patients with primary aldosteronism
What is the concordance between the adrenal vein sampling and the 18FCETO PETCT scan results
What is the effect of adrenal perfusion on 18FCETO uptake in the adrenal glands
Researchers will compare the results of the adrenal vein sampling to a 18FCETO PETCT scan to see if the PETCT can accurately identify the subtypes of primary aldosteronism Participants will
Take dexamethasone three days prior to the scan
Undergo a 18FCETO PETCT
Report burden of pre-treatment and PETCT scan
Detailed Description:
Rationale Primary aldosteronism PA is a relatively frequent and clinically relevant secondary cause of hypertension PA is usually caused by either an aldosterone producing adrenal adenoma APA or bilateral adrenal hyperplasia BAH Differentiation between these two subtypes is important as it determines the treatment of choice ie unilateral adrenalectomy in case of APA and medical treatment with a mineralocorticoid receptor antagonist in case of BAH Adrenal vein sampling AVS is considered the optimal diagnostic test for this subtyping and is recommended in most patients with PA who are a candidate for surgery AVS however is an invasive and time-consuming procedure with limited availability due to the special expertise required Additional disadvantages are the risk of procedure related complications and the relative high costs Thus there is an unmet need for a non-invasive faster more patient friendly and less expensive diagnostic test which can distinguish between the two main subtypes of PA PETCT with para-chloro-2-18Ffluoroethyl-etomidate 18FCETO has a high specificity for the steroidogenic enzymes CYP11B1 and CYP11B2 present in the adrenal cortex and has more favourable tracer characteristics compared to 11Cmetomidate Results obtained with this novel tracer seem promising but its potential value in the subtyping of PA needs to be further established Our hypothesis is that 18FCETO PETCT is selectively taken up by aldosterone producing adrenal tissue
Objective The main objective is to investigate the uptake characteristics of 18FCETO in adrenal tissue in patients with either APA or BAH The secondary objective is to evaluate the concordance between the results of adrenal vein sampling and the results of the 18FCETO scan In addition the effect of tissue perfusion on the 18FCETO uptake by means of a 15O water scan is studied
Main trial endpoints The main trial endpoint is the investigation of 18FCETO uptake by adrenal gland tissue in patients with either APA or BAH Descriptive statistics will be used to explore uptake characteristics
Secondary trial endpoints The secondary trial end points are i the concordance between the results of adrenal vein sampling and ii the relationship between adrenal perfusion and 18FCETO uptake Trial design Prospective single-center diagnostic observational pilot study The expected duration of this study is 2 years
Trial population Adult patients gt 18 years of age with biochemically confirmed PA who underwent a successful AVS n12 are eligible for inclusion Main exclusion criteria are diabetes mellitus serious comorbidity precluding surgery and use of specific medications
Interventions Participating patients have been subjected to the routine diagnostic work-up for PA as recommended by the guideline of the European Society of Hypertension 2020 including hormonal evaluation before and after a salt-loading protocol CT or MRI of the adrenal glands and AVS Three days prior to the PETCT scans patients receive pretreatment with dexamethasone in order to enhance tracer specificity Each participant will be subjected to one additional hospital visit for the investigational diagnostic PET-CT procedure with the administration of 18FCETO which is directly preceded by a 15O water scan
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks
No adverse effects following 18FCETO and 15O water injection have been reported in the literature Pretreatment with dexamethasone is recommended for the 18FCETO PETCT and could result in mild reversible side effects hyperglycemia mood changes sleep disturbance which will be monitored by means of a non-invasive questionnaire As this is a diagnostic pilot study participating patients will not benefit directly from this investigational diagnostic procedure However patients contribute to gathering information on the application of 18FCETO PETCT potentially reducing the need for AVS in future patients
Objective The main objective is to investigate the uptake characteristics of 18FCETO in adrenal tissue in patients with either APA or BAH The secondary objective is to evaluate the concordance between the results of adrenal vein sampling and the results of the 18FCETO scan In addition the effect of tissue perfusion on the 18FCETO uptake by means of a 15O water scan is studied
Main trial endpoints The main trial endpoint is the investigation of 18FCETO uptake by adrenal gland tissue in patients with either APA or BAH Descriptive statistics will be used to explore uptake characteristics
Secondary trial endpoints The secondary trial end points are i the concordance between the results of adrenal vein sampling and ii the relationship between adrenal perfusion and 18FCETO uptake Trial design Prospective single-center diagnostic observational pilot study The expected duration of this study is 2 years
Trial population Adult patients gt 18 years of age with biochemically confirmed PA who underwent a successful AVS n12 are eligible for inclusion Main exclusion criteria are diabetes mellitus serious comorbidity precluding surgery and use of specific medications
Interventions Participating patients have been subjected to the routine diagnostic work-up for PA as recommended by the guideline of the European Society of Hypertension 2020 including hormonal evaluation before and after a salt-loading protocol CT or MRI of the adrenal glands and AVS Three days prior to the PETCT scans patients receive pretreatment with dexamethasone in order to enhance tracer specificity Each participant will be subjected to one additional hospital visit for the investigational diagnostic PET-CT procedure with the administration of 18FCETO which is directly preceded by a 15O water scan
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks
No adverse effects following 18FCETO and 15O water injection have been reported in the literature Pretreatment with dexamethasone is recommended for the 18FCETO PETCT and could result in mild reversible side effects hyperglycemia mood changes sleep disturbance which will be monitored by means of a non-invasive questionnaire As this is a diagnostic pilot study participating patients will not benefit directly from this investigational diagnostic procedure However patients contribute to gathering information on the application of 18FCETO PETCT potentially reducing the need for AVS in future patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None