NCT05815069

Brief Summary

The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for \[18F\]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of \[18F\]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

March 22, 2023

Last Update Submit

August 5, 2023

Conditions

Aldosterone-Producing Adenoma

Outcome Measures

Primary Outcomes (2)

  • Maximum standardized uptake value(SUVmax)

    Maximum standardized uptake value of suspicious adrenal lesion on \[18F\]AlF-NOTA-pentixather PET/CT

    Within a week of completion of imaging

  • target background ratio(TBR)

    The ratio of SUVmax of adrenal lesions to SUVmean of the liver background and the ratio of SUVmax of adrenal lesions to SUVmean of the contralateral adrenal gland were analyzed in the study as the target background ratio(TBR).

    Within a week of completion of imaging

Study Arms (1)

[18F]AlF-NOTA-pentixather

EXPERIMENTAL

No special preparation such as fasting and fasting is required before the examination. The radiotracer 18F-AlF-NOTA-pentiaxther PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight, and the drug was synthesized by the Department of Nuclear Medicine of Sichuan Provincial People's Hospital immediately before the examination. Before the examination, patients were instructed to urinate as many times as possible to reduce the possible influence of the residual radiotracer in the renal pelvis and calyces on the image quality. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were reconstructed iteratively.

Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT

Interventions

[18F]AlF-NOTA-pentixather PET/CTDIAGNOSTIC_TEST

The radiotracer 18F-AlF-NOTA-pentixather PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were iteratively reconstructed. Patients who have undergone surgery routinely undergo pathological examination.

Also known as: pathological examination
[18F]AlF-NOTA-pentixather

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent hypertension or refractory hypertension (blood pressure \>140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \>160/100 mmHg.
  • Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure \>160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).
  • Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition.
  • Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR \<30 (ng/dl)/(ng/ml/h) were also included in the study.

You may not qualify if:

  • Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception.
  • Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes.
  • Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol.
  • Other conditions deemed by the investigator to be inappropriate for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (3)

  • Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.

    PMID: 32206838RESULT

  • Poschenrieder A, Osl T, Schottelius M, Hoffmann F, Wirtz M, Schwaiger M, Wester HJ. First 18F-Labeled Pentixafor-Based Imaging Agent for PET Imaging of CXCR4 Expression In Vivo. Tomography. 2016 Jun;2(2):85-93. doi: 10.18383/j.tom.2016.00130.

    PMID: 30042959RESULT

  • Heinze B, Fuss CT, Mulatero P, Beuschlein F, Reincke M, Mustafa M, Schirbel A, Deutschbein T, Williams TA, Rhayem Y, Quinkler M, Rayes N, Monticone S, Wild V, Gomez-Sanchez CE, Reis AC, Petersenn S, Wester HJ, Kropf S, Fassnacht M, Lang K, Herrmann K, Buck AK, Bluemel C, Hahner S. Targeting CXCR4 (CXC Chemokine Receptor Type 4) for Molecular Imaging of Aldosterone-Producing Adenoma. Hypertension. 2018 Feb;71(2):317-325. doi: 10.1161/HYPERTENSIONAHA.117.09975. Epub 2017 Dec 26.

    PMID: 29279316RESULT

MeSH Terms

Conditions

Adrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Wei Zhang, Ph.D

    Sichuan Academy of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Wei Zhang, Ph.D

CONTACT

86+02887393368zhangwscd@uestc.edu.cn

Limeng He, MA.Sc

CONTACT

86+17311397283hlmxnykdx@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate senior physician

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 18, 2023

Study Start

January 7, 2023

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)