Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
2 other identifiers
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
February 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 20, 2026
March 31, 2026
16.9 years
December 21, 2013
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.
Subjects will be imaged every 6-12 months until tumor is found
6-12 months
To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
subjects will be imaged every 6-12 months until tumor is found
6-12 months
Secondary Outcomes (1)
To evaluate a potential correlation between 18F-DOPA or 68Ga-DOTATATE uptake and the type of tumor, its size, SSTR expression or proliferative activity.
Ongoing
Study Arms (1)
Imaging
EXPERIMENTALAll subjects will be imaged
Interventions
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- years of age
- Medical history of ectopic Cushing syndrome or diagnosed with the possibility of ectopic Cushing syndrome
- For females of reproductive potential: agreement to use highly effective contraception for at least 2 weeks before any PET scan
- Ability of subject to understand and the willingness to sign a written informed consent document
- Stated willingness to comply with all study procedures and availability for the duration of the study
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation; the radiation associated with PET and CT scans may be harmful to a developing fetus. Likewise the ingestion of radionuclides in breast milk has an unknown risk to an infant.
- Evidence of severe active infection
- Clinically significantly impaired cardiovascular function, abnormal coagulation in the absence of medically-indicated treatment (PT and PTT elevated by 30% above the normal values), hematopoietic (hematocrit less than 30%, hemoglobin below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm\^3), hepatic (liver enzymes elevated by 4-fold above normal values), or renal function (plasma creatinine level over 2.1).
- Body weight over 136 kg, which is the limit for the tables used in the scanning areas.
- Combined blood withdrawal during the six weeks preceding the study greater than 450 ml.
- Subjects who previously underwent ten or more F-DOPA PET/CT scans and ten or more DOTATATE scans.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynnette K Nieman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2013
First Posted
December 24, 2013
Study Start
February 12, 2014
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 20, 2026
Record last verified: 2026-03-31
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR, ANALYTIC CODE
- Time Frame
- Start at the time of publication, for five years unless the study investigators leave NIH
- Access Criteria
- The PI will review requests and will provide data to investigators who wish to perform meta-analysis with other manuscript results. Data will be provided as an anonymized excel spread sheet.
On request, IPD related to a publication will be made available.