CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis (NCT05839483) | Clinical Trial Compass
UnknownNot Applicable
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
China50 participantsStarted 2023-05-30
Plain-language summary
The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.
Who can participate
Age range
18 Years – 70 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 with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test.
* The patient has provided written informed consent authorisation before participating in the study.
* The patient is 18 to 70 years of age at the time of consent.
Exclusion Criteria:
* Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, or adrenalectomy.
* Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3).
* Suspicion of adrenocortical carcinoma.
* Severe comorbidity potentially interfering with treatment or health-related quality of life.
* Patients need to take drugs that interfere with clinical research.
* Any medical condition present that in the opinion of the investigator will affect patients clinical status.
* Pregnancy or lactation.
* Estimated glomerular filtration rate \<40mL/min/1.73m2.
* Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.
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
renin
Timeframe: immediately after admission
2
aldosterone
Timeframe: immediately after admission
3
SUVmax
Timeframe: immediately after 68Ga-PentixaFor PET imaging
4
sensitivity
Timeframe: immediately after pathological examination
5
specificity
Timeframe: immediately after pathological examination
6
positive predictive value,PPV
Timeframe: immediately after pathological examination
7
negative predictive value, NPV
Timeframe: immediately after pathological examination