Aldosterone-Producing AdenomaNCT05839483
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis
A study testing CXCR4 in people with Aldosterone-Producing Adenoma, run by Zhongnan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aldosterone-Producing Adenoma
- What is being tested?
- CXCR4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 31 Dec 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy or lactation.
- Estimated glomerular filtration rate <40mL/min/1.73m2.
- Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhe Meng, +86 15387041020
About this study
Official title: A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
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.
- Conditions
- Aldosterone-Producing Adenoma
- Being tested
- CXCR4
- Keywords
- Hypertension, Hypokalemia, Adrenal adenoma
- Medical subject headings
- Adrenocortical Adenoma, Hypertension, Hypokalemia, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4Diagnostic test
Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| CXCR4 | Experimental | scanned by 68Ga-PentixaFor PET imaging Receives: Diagnostic Test: CXCR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
renin
measure the level of renin in blood
Measured: immediately after admission
aldosterone
measure the level of aldosterone in blood
Measured: immediately after admission
SUVmax
measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal
Measured: immediately after 68Ga-PentixaFor PET imaging
sensitivity
the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Measured: immediately after pathological examination
specificity
the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Measured: immediately after pathological examination
positive predictive value,PPV
the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Measured: immediately after pathological examination
negative predictive value, NPV
the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Measured: immediately after pathological examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start30 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aldosterone-Producing AdenomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Meng, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839483
- Sponsor's protocol ID
- Zhe Meng
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui Y, Zhang Y, Ding J, Wang H, Ma X, Wang O, Chang X, Sun H, Huo L, Tong A. A Rare Aldosterone-Producing Adenoma Detected by 68Ga-pentixafor PET-CT: A Case Report and Literature Review. Front Endocrinol (Lausanne). 2019 Nov 29;10:810. doi: 10.3389/fendo.2019.00810. eCollection 2019.
PubMed 31849839Chaman Baz AH, van de Wiel E, Groenewoud H, Arntz M, Gotthardt M, Deinum J, Langenhuijsen J. CXCR4-directed [68Ga]Ga-PentixaFor PET/CT versus adrenal vein sampling performance: a study protocol for a randomised two-step controlled diagnoStic Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS). BMJ Open. 2022 Aug 23;12(8):e060779. doi: 10.1136/bmjopen-2022-060779.
PubMed 35998969Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.
PubMed 32206838
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT05839483
- Acronym / sponsor ID
- Zhe Meng
- Conditions
- Aldosterone-Producing Adenoma
- Keywords
- Hypertension, Hypokalemia, Adrenal adenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 May 2023 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXCR4 | Experimental | Diagnostic Test: CXCR4scanned by 68Ga-PentixaFor PET imaging |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| CXCR4Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging. | Diagnostic test | CXCR4 |
Primary outcome
renin
Time frame: immediately after admission
measure the level of renin in blood
aldosterone
Time frame: immediately after admission
measure the level of aldosterone in blood
SUVmax
Time frame: immediately after 68Ga-PentixaFor PET imaging
measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal
sensitivity
Time frame: immediately after pathological examination
the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
specificity
Time frame: immediately after pathological examination
the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
positive predictive value,PPV
Time frame: immediately after pathological examination
the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
negative predictive value, NPV
Time frame: immediately after pathological examination
the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Results publication: PubMed 31849839Cui Y, Zhang Y, Ding J, Wang H, Ma X, Wang O, Chang X, Sun H, Huo L, Tong A. A Rare Aldosterone-Producing Adenoma Detected by 68Ga-pentixafor PET-CT: A Case Report and Literature Review. Front Endocrinol (Lausanne). 2019 Nov 29;10:810. doi: 10.3389/fendo.2019.00810. eCollection 2019.
- Results publication: PubMed 35998969Chaman Baz AH, van de Wiel E, Groenewoud H, Arntz M, Gotthardt M, Deinum J, Langenhuijsen J. CXCR4-directed [68Ga]Ga-PentixaFor PET/CT versus adrenal vein sampling performance: a study protocol for a randomised two-step controlled diagnoStic Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS). BMJ Open. 2022 Aug 23;12(8):e060779. doi: 10.1136/bmjopen-2022-060779.
- Results publication: PubMed 32206838Ding J, Zhang Y, Wen J, Zhang H, Wang H, Luo Y, Pan Q, Zhu W, Wang X, Yao S, Kreissl MC, Hacker M, Tong A, Huo L, Li X. Imaging CXCR4 expression in patients with suspected primary hyperaldosteronism. Eur J Nucl Med Mol Imaging. 2020 Oct;47(11):2656-2665. doi: 10.1007/s00259-020-04722-0. Epub 2020 Mar 23.
- Individual participant dataSharing planned: No
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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.
Zhe Meng principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CXCR4 in people with Aldosterone-Producing Adenoma, run by Zhongnan 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 3 inclusion and 9 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 17 Jul 2023. 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.
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 Zhe Meng (+86 15387041020, mengzhe@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renin (time frame: immediately after admission). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839483, which also lists 3 linked publications.
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 17 Jul 2023.