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NCT02019706From ClinicalTrials.govRecruiting

Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome

  • ACTH
  • Cushing's Syndrome

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrolment target
80
Started
12 February 2014
Main results due
31 December 2030
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 80 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
* INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

* 18 - 90 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

EXCLUSION CRITERIA:

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).
* Based on the clinical judgment of the attending physician, other medical problems may prompt exclusion.
* 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

...

Study sites(1)

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT02019706. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome | Trialion