Brain Cancer Trial, Recruiting NCT04569591 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Condition: Brain Cancer
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Brain Cancer Trial, Recruiting

NCT04569591
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 8 or older who have been diagnosed with Cushing's disease based on medical records, with lab results confirming the condition
  • People whose MRI of the pituitary gland either showed no tumor or only a possible tumor (not a confirmed tumor)
  • People who had an MRI of the pituitary gland, with and without contrast dye, within the past 9 months
  • People newly diagnosed with Cushing's disease who have had a specific blood sampling procedure from veins near the pituitary gland (called IPSS) performed
  • People who are able to have a PET scan while awake, without needing general anesthesia
  • People who are able to give informed consent to take part — or, in the case of children, whose parent or guardian is able to give consent on their behalf
  • People who are willing and medically suitable to have surgery to remove an ACTH-producing pituitary tumor within 24 weeks of the PET scan
  • People with normal liver function, confirmed by blood tests taken within 14 days before the scan
  • People who have previously tolerated a medication called DDAVP without problems (including as part of their Cushing's disease diagnosis process)

Who may not be able to join:

  • People who are currently pregnant or breastfeeding
  • People with significantly reduced kidney function, a combined liver and kidney condition (hepatorenal syndrome), a history of difficulty passing urine, or who have previously had a liver or kidney transplant
  • People with low sodium levels in their blood (below a certain threshold)
  • People currently diagnosed with chest pain (angina), significant heart artery disease, heart failure, or a condition called SIADH (a hormone condition that causes the body to retain too much water)
  • People with uncontrolled high blood pressure above a certain level
  • People with severe or symptomatic low blood pressure
  • People currently taking certain medications, including:
    • Blood pressure-supporting drugs such as phenylephrine, dopamine, or vasopressin
    • Certain medications that can lower sodium levels, including some anti-inflammatory painkillers (NSAIDs, within 4 days of testing), certain water tablets (loop diuretics), chlorpromazine, chlorpropamide, cisplatin, certain strong pain medications (opiate-based, within 48 hours of testing), or vincristine
    • Certain medications that affect how DDAVP works in the body, including carbamazepine, lamotrigine, or tolvaptan
  • People with a condition causing excessive thirst and fluid intake (habitual or psychogenic polydipsia)
  • People with a history of a specific blood clotting disorder called Type IIB von Willebrand's disease
  • People with a blood sugar level above a certain level on the day of the scan, before the scan begins
  • People with a known intolerance or allergic reaction to DDAVP
  • Children under the age of 8, as PET scans at that age typically require general anesthesia, which carries greater risk
  • Women who are able to become pregnant and return a positive pregnancy test within 24 hours before the PET scan

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Prashant Chittiboina, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Phone: (301) 496-2921

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
9 March 2026
Est. completion
26 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov