Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with adrenal masses suspected to be aldosterone-producing adenomas based on routine imaging (e.g., CT scans), or clinically diagnosed primary aldosteronism patients requiring subtyping
Signed written informed consent, with willingness and ability to comply with study procedures.
Female participants must be surgically sterilized or postmenopausal for over a year; if not, reliable contraception is required.
Male participants must use reliable contraception during the study and refrain from sperm donation.
Disqualifiers
Severe neurological disorders, or any significant diseases affecting the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, or immune systems, or other serious illnesses.
Diagnosis of claustrophobia.
History of drug abuse or alcohol dependence.
Pregnant or breastfeeding women.
Trial design
Design model
Single group
Treatments tested in this trial
Al18F-NOTA-Pentixafor PET/CT
Combination productParticipants 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Al18F-NOTA-Pentixafor PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 )3
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)Secondary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov