CXCR4 Targeted PET Imaging in the Diagnosis and Identific... | NCT06183554

Studies
CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism

NCT06183554

Sponsor

Xiao Chen

Status

Unknown status

Last Update Posted

Jan 3, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Primary Aldosteronism

Interventions

CXCR4

Countries

China

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2023Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Dec 14, 2023

First Submission Date that Met QC Criteria

Dec 14, 2023

First Posted Date

Dec 27, 2023Actual

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

Dec 29, 2023

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) positron emission tomography (PET) imaging in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.

Detailed Description

Record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected PA.
PET image analysis: Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the mean standardized uptake value (SUVmean) of normal liver, the SUVmean of adjacent normal adrenal tissue, the ratio of the lesional SUVmax to the normal liver SUVmean (LLR), and the ratio of the lesional SUVmax to the adjacent adrenal tissue SUVmean (LAR).
Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (CYP11B2) and CXCR4.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
CXCR4	Diagnostic Test	Patients with clinical suspected primary aldosteronism will receive a CXCR4 PET imaging.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardised uptake values	Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging	completed within one week after the PET examination

Secondary Outcomes

Measure	Description	Time Frame
Immunohistochemical results	Immunohistochemical evaluation of postoperative adrenal specimens	completed within one week after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persistent hypertension with blood pressure > 150/100 mmHg, refractory hypertension (blood pressure >140/90 mmHg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure >140/90 mmHg;
Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L);
Positive intravenous salt-loading test or captopril test;
Hypertension and adrenal lesions;
Patient ≥18 years of age at the time of consent;
Provided written informed consent authorisation before participating in the study.

Exclusion Criteria:

Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;
Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)；
Suspicion of adrenocortical carcinoma；
Severe comorbidity potentially interfering with treatment or HRQoL；
Requirement of medication interfering with the study protocol；
Pregnancy or lactation；
Estimated glomerular filtration rate <40 mL/min/1.73 m².

Accepts Healthy Volunteers

Yes

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

The subjects the investigators selected are adults who are not restricted by gender.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiao Chen, Ph.D	Contact	+8615922970174		xiaochen229@foxmail.com

Overall Officials

Name	Affiliation	Role
Xiao Chen, Ph.D	Daping Hospital, Army Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine, Daping Hospital of Army Medical University	Recruiting	Chongqing	Chongqing Municipality	400010	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36795418	Background	Hu J, Xu T, Shen H, Song Y, Yang J, Zhang A, Ding H, Xing N, Li Z, Qiu L, Ma L, Yang Y, Feng Z, Du Z, He W, Sun Y, Cai J, Li Q, Chen Y, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Accuracy of Gallium-68 Pentixafor Positron Emission Tomography-Computed Tomography for Subtyping Diagnosis of Primary Aldosteronism. JAMA Netw Open. 2023 Feb 1;6(2):e2255609. doi: 10.1001/jamanetworkopen.2022.55609.

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