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Can a new PET scan light up hidden adrenal tumors causing high blood pressure?

NCT ID NCT05815069

Diagnosis Sponsor: Sichuan Provincial People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial is testing whether a new radioactive tracer, [18F]AlF-NOTA-pentixather, can accurately identify aldosterone-producing adenomas (benign adrenal tumors) in people with primary aldosteronism—a condition where the adrenal glands make too much aldosterone, leading to high blood pressure and low potassium. About 20 participants with suspected primary aldosteronism will receive the tracer and undergo a PET/CT scan. The scan's results will be compared with the final pathology after surgery to see how sensitive and specific the test is for diagnosing these tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A radioactive tracer called [18F]AlF-NOTA-pentixather, given by injection for a PET/CT scan
What this could lead to
If it works, this could offer a more accurate, non-invasive way to find aldosterone-producing adrenal tumors, potentially guiding better treatment and avoiding unnecessary surgery.
What could go wrong
This is a small early-stage study (20 people), so results may not apply broadly. The tracer's accuracy needs confirmation against surgical findings, and there may be false positives or negatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Persistent hypertension or refractory hypertension (blood pressure \>140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure \>160/100 mmHg. * Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure \>160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h). * Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition. * Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR \<30 (ng/dl)/(ng/ml/h) were also included in the study. Exclusion Criteria: * Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception. * Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes. * Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol. * Other conditions deemed by the investigator to be inappropriate for participation in this study.

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Conditions

The condition(s) this trial relates to.

adrenal cortex adenoma aldosterone-producing adrenal cortex adenoma hyperaldosteronism primary aldosteronism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aldosterone-producing adenoma Primary hyperaldosteronism

Contacts and locations

Locations

  • Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

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