Primary AldosteronismPhase 1/2NCT06773663
Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism
A Phase 1/2 study testing Al18F-NOTA-Pentixafor PET/CT in people with Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma
- What is being tested?
- Al18F-NOTA-Pentixafor PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2023to 30 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Poor venous access that would preclude repeated venipuncture.
- Use of experimental drugs or devices within one month prior to the study, where the safety or efficacy has not been established.
- Any condition that the study investigators deem could pose potential harm or jeopardize participant safety.
Trial locations and contacts
1 site in 1 country.
Li Huo, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing
About this study
Official title: Evaluation of Biodistribution, Dosimetry, Diagnostic and Surgery-guiding Ability of Al18F-NOTA-Pentixafor PET Imaging for Patients With Primary Aldosteronism: A Prospective, Single-center Study
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.
Read the detailed description
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.
- Being tested
- Al18F-NOTA-Pentixafor PET/CT
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-NOTA-Pentixafor PET/CTCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Al18F-NOTA-Pentixafor PET/CT | Experimental | Evaluation of dosimetry, safety, diagnostic accuracy, and surgical guidance ability of Al18F-NOTA-Pentixafor PET/CT in patients with primary aldosteronism Receives: Combination Product: Al18F-NOTA-Pentixafor PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Al18F-NOTA-Pentixafor
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Measured: 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 .
Measured: 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 :
- Complete Clinical Success:Blood pressure is completely normalized without the need for antihypertensive medications.
- Partial Clinical Success:Blood pressure improves, requiring fewer antihypertensive medications or easier control.
- Absent Clinical Success:No significant improvement in blood pressure, and medication requirements remain unchanged.
- Complete Biochemical Success: Postoperative aldosterone-to-renin ratio normalizes, indicating full correction of aldosterone overproduction.
- Partial Biochemical Success: Aldosterone levels decrease but do not fully normalize.
- Absent Biochemical Success: No significant improvement in biochemical markers, suggesting persistent aldosterone overproduction.
Measured: 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 (2)
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.
Measured: From study completion to 6 months after completion.
Absorbed dose of target organs
Absorbed dose of target organs were calculated using HERMES software.
Measured: From study completion to 6 months after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start30 Dec 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773663
- Sponsor's protocol ID
- K5164
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biodistribution, Dosimetry, Diagnostic and Surgery-guiding Ability of Al18F-NOTA-Pentixafor PET Imaging for Patients With Primary Aldosteronism: A Prospective, Single-center Study
- ClinicalTrials.gov ID
- NCT06773663
- Acronym / sponsor ID
- K5164
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-NOTA-Pentixafor PET/CT | Experimental | Combination Product: Al18F-NOTA-Pentixafor PET/CTEvaluation of dosimetry, safety, diagnostic accuracy, and surgical guidance ability of Al18F-NOTA-Pentixafor PET/CT in patients with primary aldosteronism |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Poor venous access that would preclude repeated venipuncture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Al18F-NOTA-Pentixafor PET/CTParticipants 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. | Combination product | Al18F-NOTA-Pentixafor PET/CT |
Primary outcome
Safety of Al18F-NOTA-Pentixafor
Time frame: From radiotracer injection to 24 hours post-injection.
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Diagnostic accuracy of Al18F-NOTA-Pentixafor PET/CT for PA
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 )
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 .
Surgical outcomes guided by Al18F-NOTA-Pentixafor PET/CT
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)
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.
2 secondary outcomes
SUVmax of normal organs
Time frame: From study completion to 6 months after completion.
Absorbed dose of target organs
Time frame: From study completion to 6 months after completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Huo, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Al18F-NOTA-Pentixafor PET/CT in people with Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinchun Yan, PhD (+86 18513489856, xcyanpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Al18F-NOTA-Pentixafor (time frame: From radiotracer injection to 24 hours post-injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.