Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult population (aged 18 years or order);

patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests);

patients who had scheduled 68Ga-BNU-PSMA PET/CT scan;

patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee;

Disqualifiers

patients with pregnancy;

the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-Pentixafor

    Diagnostic test

    Each patient receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT scan within specified time.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 68Ga-PentixaforExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Standardized uptake value (SUV)

Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.

Time frame
through study completion,an average of 3 years

Secondary outcomes

1

SAAE treatment evaluation

68Ga-Pentixafor PET/CT imaging to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE.

Time frame
through study completion,an average of 3 years

Other outcomes

Sponsors and contacts

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