Nuclear Imaging for Subtype Diagnosis of Primary Aldoster... | NCT05472493

Studies
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

NCT05472493

Sponsor

University of Calgary

Status

Recruiting

Last Update Posted

Jul 24, 2024Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Primary Aldosteronism

Interventions

[18-F]CETO

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Jul 18, 2022

First Submission Date that Met QC Criteria

Jul 22, 2022

First Posted Date

Jul 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-[18F]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard.

Detailed Description

This is a phase II study (with targeted recruitment of 30 participants) designed to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-[18F]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard. Subjects consenting to study participation will receive the [18-F] CETO followed by the PET/CT scan.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CETO	Experimental	The consented participants will receive the [18-F] CETO through the IV and a PET/CT scan afterwards.	Biological: [18-F]CETO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[18-F]CETO	Biological	PET/CT will be performed; Non-contrast CT images will be acquired over the adrenals (slice width, ~3 mm). CETO (~2.5 MBq/kg; up to 365 MBq +/- 20%) will be administered as a single dose intravenously and dynamic PET images will be acquired from ~0-90 minutes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure is diagnostic test accuracy (expressed as sensitivity, specificity, positive predictive value, and negative predictive value) for CETO PET/CT using adrenal vein sampling as a reference standard.		It will be measured using adrenal vein sampling approximately the same time as the CETO PET/CT.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with hypertension
Individuals with an elevated screening adrenal renin ratio (ARR)
Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ or plus a discrete adrenal nodule or nodules (1 cm or greater) with concordant lateralization on AVS.

Exclusion Criteria:

Individuals with chronic kidney disease (estimated glomerular filtration rate <40 mL/min/1.73m2),
Individuals with a history of uncontrolled severe hypertension (>180/110 mmHg), severe uncontrolled diabetes, suspected or proven hypercortisolism (e.g., cortisol-secreting adrenal adenoma), or individuals with an anatomical disease of the liver (e.g., hepatic adenoma or focal nodular hyperplasia)
Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.
Pregnancy, lactation, and pheochromocytoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Leung, MD	Contact	(403) 955-8358		aacleung@ucalgary.ca

Overall Officials

Name	Affiliation	Role
Alexander Leung, MD	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary	Recruiting	Calgary	Alberta		Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006929	Hyperaldosteronism

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided