A Phase 1/2 interventional study of Al18F-NOTA-Pentixafor PET/CT in Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Diagnostic
This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-Pentixafor PET imaging in patients with primary aldosteronism. And evaluates the potential of Al18F-NOTA-Pentixafor PET imaging in surgical strategy guidance.
Hypertension has a high prevalence, being a leading cause of premature death in 1.4 billion adults worldwide. Primary aldosteronism (PA) is the most common cause of secondary hypertension. Guidelines recommend that 50% of people with hypertension should be screened for PA, yet fewer than 1% of PA patients have undergone screening and treatment. Aldosterone-producing adenoma (APA) and idiopathic hyperaldosteronism (IHA) are the primary subtypes of PA, accounting for approximately 35% and 60% of cases, respectively. Early diagnosis and treatment can improve prognosis and enhance patients' quality of life. Screening for PA, particularly in patients with resistant hypertension or newly diagnosed hypertension, has practical clinical significance.
Currently, adrenal vein sampling (AVS) is considered the "gold standard" for PA subtyping, allowing for the identification of unilateral dominant secretion, with a sensitivity of 95% and a specificity of 100%. However, AVS is an invasive procedure, expensive, requires hospitalization, is technically challenging, and carries risks of catheterization failure and post-procedural complications. Thus, it is difficult to implement AVS on a large scale across medical facilities. Conventional imaging techniques such as CT have low detection efficacy for small adrenal nodules, falling short of clinical diagnostic and therapeutic needs.
CXCR4 is a typical G-protein-coupled receptor primarily located on the cell membrane. Upon activation, it stimulates cell migration and activation, playing a key role in hematopoiesis, immunity, inflammation, and cancer regulation. Recent studies have found that CXCR4 is highly expressed on the cell membrane of APA and is significantly correlated with the expression level of aldosterone synthase (CYP11B2), while it is expressed at low levels in non-functional adenomas. The nuclear medicine molecular probe, 68Ga-Pentixafor, is a specific ligand for CXCR4. By specifically binding to CXCR4 receptors on the cell membrane, it provides functional imaging through PET/CT, offering a simple, direct, and effective reference for PA subtyping and clinical decision-making.
Al18F-NOTA-Pentixafor is an imaging agent targeting CXCR4, and in vitro experiments have shown its specific binding to CXCR4 with high affinity. Therefore, Al18F-NOTA-Pentixafor PET imaging can be used for the non-invasive localization of all CXCR4-positive lesions in vivo, including APA. However, currently, only limited research has investigated the application of Al18F-CXCR4 receptor imaging in PA, and no studies have yet examined its potential value for surgical guidance in patients with PA. Al18F-NOTA-Pentixafor can be synthesized automatically in large quantities within a short time. If its imaging performance is not inferior to that of 68Ga-Pentixafor, it would be more advantageous for large-scale clinical application.
This prospective, single-center study aims to assess the biodistribution, dosimetry, safety, and diagnostic efficacy of Al18F-NOTA-Pentixafor PET imaging in patients with primary aldosteronism. Furthermore, it evaluates the potential of Al18F-NOTA-Pentixafor PET imaging to guide surgical strategies for these patients.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 150 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of dosimetry, safety, diagnostic accuracy, and surgical guidance ability of Al18F-NOTA-Pentixafor PET/CT in patients with primary aldosteronism
Combination Product: Al18F-NOTA-Pentixafor PET/CT
Participants will receive an intravenous injection of Al18F-NOTA-Pentixafor, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. CT and PET imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.
Safety of Al18F-NOTA-Pentixafor
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Time frame: From radiotracer injection to 24 hours post-injection.
Diagnostic accuracy of Al18F-NOTA-Pentixafor PET/CT for PA
SUVmax and SUVmean of adrenal lesions, normal adrenal glands, and liver will be measured. The lesion-to-liver ratio (LLR) and lesion-to-normal adrenal ratio (LAR) will be calculated. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or adrenal vein sampling (AVS) findings will serve as the reference standard to determine the sensitivity and specificity .
Time frame: Through study completion, 1-1.5 years (from enrollment to to the final clinical or pathological diagnosis at 6-month follow-up after Al18F-NOTA-Pentixafor PET/CT )
Surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT
Primary Aldosteronism Surgical Outcome (PASO) Criteria : 1. Complete Clinical Success:Blood pressure is completely normalized without the need for antihypertensive medications. 2. Partial Clinical Success:Blood pressure improves, requiring fewer antihypertensive medications or easier control. 3. Absent Clinical Success:No significant improvement in blood pressure, and medication requirements remain unchanged. 4. Complete Biochemical Success: Postoperative aldosterone-to-renin ratio normalizes, indicating full correction of aldosterone overproduction. 5. Partial Biochemical Success: Aldosterone levels decrease but do not fully normalize. 6. Absent Biochemical Success: No significant improvement in biochemical markers, suggesting persistent aldosterone overproduction.
Time frame: Through study completion, 1-1.5 years (from enrollment to 6-month follow-up after surgery guided by Al18F-NOTA-Pentixafor PET/CT)
SUVmax of normal organs
The biodistribution of Al18F-NOTA-Pentixafor will be assessed in the following organs: pituitary gland, parotid glands, thyroid glands, lungs, blood pool, liver, spleen, pancreas (including the head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands. The SUVmax values for these organs will be measured and documented.
Time frame: From study completion to 6 months after completion.
Absorbed dose of target organs
Absorbed dose of target organs were calculated using HERMES software.
Time frame: From study completion to 6 months after completion.
Started Dec 2023 (actual). Primary completion is estimated for May 2026, 29 months after the start.
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