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

Primary Purpose

Aldosterone-Producing Adenoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
[18F]AlF-NOTA-pentixather PET/CT
Sponsored by
Sichuan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aldosterone-Producing Adenoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sichuan Academy of Medical Sciences.Sichuan Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]AlF-NOTA-pentixather

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 22, 2023
Last Updated
August 5, 2023
Sponsor
Sichuan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05815069
Brief Title
[18F]AlF-NOTA-pentixather PET/CT in Patients With Suspected Primary Hyperaldosteronism
Official Title
Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aldosterone-Producing Adenoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]AlF-NOTA-pentixather
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]AlF-NOTA-pentixather PET/CT
Other Intervention Name(s)
pathological examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum standardized uptake value(SUVmax)
Description
Maximum standardized uptake value of suspicious adrenal lesion on [18F]AlF-NOTA-pentixather PET/CT
Time Frame
Within a week of completion of imaging
Title
target background ratio(TBR)
Description
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).
Time Frame
Within a week of completion of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, Ph.D
Phone
86+02887393368
Email
zhangwscd@uestc.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Limeng He, MA.Sc
Phone
86+17311397283
Email
hlmxnykdx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Ph.D
Organizational Affiliation
Sichuan Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Ph.D
Phone
86+02887393368
Email
zhangwscd@uestc.edu.cn
First Name & Middle Initial & Last Name & Degree
Limeng He, MA.Sc
Email
hlmxnykdx@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32206838
Citation
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.
Results Reference
result
PubMed Identifier
30042959
Citation
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.
Results Reference
result
PubMed Identifier
29279316
Citation
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.
Results Reference
result

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

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