Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather (NCT06581744) | Clinical Trial Compass
RecruitingNot Applicable
Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather
China20 participantsStarted 2024-06-12
Plain-language summary
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. \[18F\]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent(\[18F\]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. \[18F\]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram \[ID/g\] at 1 hour post injection\[p.i.\]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of \[18F\]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the \[18F\]AlF-NOTA-Pentixather as a probe for APA.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients diagnosed with primary aldosteronism and willing to undergo surgery
. Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
. Postoperative recurrence in patients with primary aldosteronism
Exclusion criteria
. Pregnant and lactating women.
. Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
. There are other situations where patients are not suitable for this examination
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
Timeframe: 6 month
2
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA