New scan could spot 'Invisible' brain tumors in Cushing's patients

NCT ID NCT04569591

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Recruiting now This study
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Cancelled before anyone took part.

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special PET scan, combined with a drug called desmopressin, can find tiny pituitary tumors that standard MRI scans miss in people with Cushing's disease. About 22 participants will receive the drug and a radioactive tracer, then undergo imaging. The goal is to see if this method accurately locates tumors, which could help surgeons remove them more effectively.

What this could mean

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

Active substance
Desmopressin acetate (DDAVP)
What this could lead to
If successful, this could provide a new way to locate small pituitary tumors that are invisible on MRI, helping surgeons remove them more precisely.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply broadly. The PET scan may still miss some tumors or give false positives.

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

8 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Subjects aged 8 or older with biochemical evidence of Cushing s disease and a clinical MRI pituitary neuroradiology result of negative or possible adenoma (e.g. "no tumor" or "possible tumor") 2. MRI of the pituitary gland with and without contrast obtained within 9 months of screening 3. For newly diagnosed Cushing s disease cases, IPSS is required. 4. Ability to undergo PET-imaging without general anesthesia 5. Ability to provide informed consent for study participation (parents or guardians in the case of minors) 6. Clinical diagnosis of Cushing s disease based on documented medical records 7. Surgical candidate for and subject agrees to resection of ACTH producing pituitary adenoma within 24 weeks of PET-imaging 8. Normal liver function as evidenced by liver enzyme tests completed within 14 days before injection of radiopharmaceutical: SGOT, SGPT \<= 5 x upper limit of normal; bilirubin \<= 2 x upper limit of normal 9. Tolerance of a previous infusion of DDAVP, including as part of workup and diagnosis of Cushing's disease EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current pregnancy or lactation 2. Glomerular filtration rate \< 50 mL/min/1.73 m\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation. 3. Hyponatremia (serum sodium below 135 mmol/L) 4. Current diagnosis of angina, significant coronary artery disease, congestive heart failure, or SIADH due to risk of fluid overload and/or hyponatremia. 5. Uncontrolled hypertension (blood pressure \>150/95 mmHg) due to risk of further increase if fluid overload occurs. 6. Uncontrolled, severe hypotension (sustained blood pressure \<90/60), or symptomatic hypotension. 7. Current use of any of the following medications: * Vasopressors: phenylephrine, dopamine and vasopressin * Drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs) within 4 days of testing, loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide), chlorpromazine, chlorpropamide, cisplatin, opiate agonists within 48 hours of testing, and/or vincristine. * Drugs that interfere with DDAVP duration of action or potency: carbamazepine, lamotrigine, and/or tolvaptan 8. Habitual or psychogenic polydipsia, due to increased risk of hyponatremia 9. History of Type IIB von Willebrand s disease due to risk for thrombosis. 10. Elevated blood glucose level above 200 mg/dL on the day of the scan prior to FDG administration. 11. Known intolerance to DDAVP INCLUSION OF VULNERABLE PARTICIPANTS: * Children: Children age 8 and older are included in this protocol. More than half of the subjects with CD requiring transsphenoidal surgery at the NIH are children. The knowledge gained by the use of DDAVP PET imaging in children with MR-invisible tumors will provide generalizable knowledge in the treatment of CD in this population. Children under the age of 8 usually require anesthesia for a PET scan, which involves greater risk. Therefore, children under the age of 8 will be excluded from participation. * Pregnant or lactating women: Pregnant and lactating women will be excluded from participation. The PET radiopharmaceutical used in this study can be harmful to a developing fetus. Therefore women who are able to become pregnant will have a pregnancy test performed within 24 hours before PET imaging. Individuals will not be able to participate in PET scanning if the pregnancy test results positive.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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