[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism

NCT ID: NCT05815069

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-07

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aldosterone-Producing Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[18F]AlF-NOTA-pentixather

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_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.

Interventions

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

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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pathological examination

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao Wang

Associate senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhang, Ph.D

Role: STUDY_CHAIR

Sichuan Academy of Medical Sciences

Locations

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

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhang, Ph.D

Role: CONTACT

86+02887393368

Limeng He, MA.Sc

Role: CONTACT

86+17311397283

Facility Contacts

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Wei Zhang, Ph.D

Role: primary

86+02887393368

Limeng He, MA.Sc

Role: backup

References

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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.

Reference Type RESULT
PMID: 32206838 (View on PubMed)

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.

Reference Type RESULT
PMID: 30042959 (View on PubMed)

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.

Reference Type RESULT
PMID: 29279316 (View on PubMed)

Other Identifiers

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SCPHNM2

Identifier Type: -

Identifier Source: org_study_id

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