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NCT04569591 · ClinicalTrials.gov registry record · NA
DDAVP for Pituitary Adenoma
A NA study of Pituitary Adenoma and Cushing's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- NA
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04569591: Recruiting NA study of Pituitary Adenoma and Cushing's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT04569591 is a NA study of Pituitary Adenoma and Cushing's Disease that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 22 participants, below the 286-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569591, a NA study of Pituitary Adenoma and Cushing's Disease, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for PET-imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo FDG PET-imaging with DDAVP stimulation. Intravenous FDG will be given approximately four hours following DDAVP administration. Within 12 weeks after completion of the FDG high-resolution PET scan, patients will undergo surgical resection of the pituitary adenoma. Surgical and histological confirmation of adenoma location will be noted. All images will be read independently by neuroradiologists blinded to clinical and histopathological outcomes. The diagnostic and localization accuracy of PET-imaging will be assessed by comparing the PET findings with histopathology.
Primary Outcome
This endpoint will help justify whether pituitary adenomas that are invisible on MRI can be seen via another modality in order to improve tumor detection and preoperative planningdemonstrates tumor in MRI-negative cases. This will be demonstrated by assessing the accuracy and sensitivity of 18F-FDG high-resolution PET-imaging detection of ACTH-adenomas that could not be reliably detected on MR-imaging. Measures will include determining the rate of true tumor detection using PET-imaging compared
Conditions Studied
Interventions
- DRUG Desmopressin acetate
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2026-03-09 |
| Est. Completion | 2028-02-26 |
| Phase | NA |
What NCT04569591 shows while recruiting
NCT04569591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 286-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Pituitary Adenoma appearing as the primary indexed condition, and to 1 intervention - of which Desmopressin acetate is the first listed.
NCT04569591 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04569591 about?
NCT04569591 is a clinical study titled "DDAVP for Pituitary Adenoma". This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for PET-imaging will be used to detect MRI-negative pituita...
What is the current status of trial NCT04569591?
This trial is currently recruiting. It is a NA study. The enrollment target is 22 participants. The study started on 2026-03-09. Estimated completion is 2028-02-26.
What conditions does trial NCT04569591 study?
This clinical trial studies the following conditions: Pituitary Adenoma, Cushing's Disease.
What interventions are being tested in trial NCT04569591?
The interventions under investigation include: Desmopressin acetate (DRUG).
Who is sponsoring clinical trial NCT04569591?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04569591 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04569591's enrollment target sits among peer trials
22 8th of 9 higher than 2 of 9 other Pituitary Adenoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pituitary Adenoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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