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

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05815069
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
16.8
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: [18F]AlF-NOTA-pentixather PET/CT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism
Actual Study Start Date :
Jan 7, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: [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.

Diagnostic Test: [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.
Other Names:
  • pathological examination

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum standardized uptake value(SUVmax) [Within a week of completion of imaging]

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

    2. target background ratio(TBR) [Within a week of completion of imaging]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    • Study Chair: Wei Zhang, Ph.D, Sichuan Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05815069
    Other Study ID Numbers:
    • SCPHNM2
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenoma

    Study Results

    No Results Posted as of Apr 18, 2023