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NCT02019706 · ClinicalTrials.gov registry record · Phase 2
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
A Phase 2 study of Cushing's Syndrome and ACTH, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02019706 is a Phase 2 study of Cushing's Syndrome and ACTH that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 80 participants, below the 920-participant average among 4 other Cushing's Syndrome trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02019706, a Phase 2 study of Cushing's Syndrome and ACTH, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard dose of indium- 111 pentetreotide (\[111In-DTPA-D-Phe\]-pentetreotide). The sensitivity and specificity of structurally based imaging studies depends on anatomic alterations and the size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand imaging detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This protocol tests the ability of \[18F\]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET, and the somatostatin imaging analogue, 68Ga-DOTATATE-PET, to localize the source of ectopic ACTH production.
Conditions Studied
Interventions
- RADIATION CT scan
- RADIATION DOTATATE PET-CT
- RADIATION F-DOPA PET CT
- DIAGNOSTIC_TEST Routine MRI scan
- DIAGNOSTIC_TEST Gated MRI scan
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-02-12 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019706
The ClinicalTrials.gov registry entry for NCT02019706 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 920-participant average among 4 other Cushing's Syndrome trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cushing's Syndrome appearing as the primary indexed condition, and to 5 interventions - of which CT scan is the first listed.
NCT02019706 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02019706 about?
NCT02019706 is a clinical study titled "Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome". Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very det...
What is the current status of trial NCT02019706?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2014-02-12. Estimated completion is 2030-12-31.
What conditions does trial NCT02019706 study?
This clinical trial studies the following conditions: Cushing's Syndrome, ACTH.
What interventions are being tested in trial NCT02019706?
The interventions under investigation include: CT scan (RADIATION), DOTATATE PET-CT (RADIATION), F-DOPA PET CT (RADIATION), Routine MRI scan (DIAGNOSTIC_TEST), Gated MRI scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02019706?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02019706 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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