Evaluating imaging techniques for ectopic Cushing syndrome
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
PHASE2 · National Institutes of Health Clinical Center (CC) · NCT02019706
This study is testing different imaging methods to see which one best helps find the source of hormone problems in people with ectopic Cushing syndrome.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02019706 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of different imaging techniques, including 68Ga-DOTATATE PET/CT and 18F-DOPA PET, in locating the source of ectopic ACTH production in patients with Cushing syndrome. It aims to determine which imaging method has the highest sensitivity and whether a combination of these tests can improve diagnostic accuracy. The study includes patients aged 18 to 90 with a history or suspicion of ectopic Cushing syndrome and involves various imaging interventions. The findings could enhance the ability to identify the underlying tumors responsible for hormone excess.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 90 with a medical history of ectopic Cushing syndrome or a diagnosis suggesting the possibility of it.
Not a fit: Patients who are pregnant, lactating, or have severe active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate localization of tumors causing ectopic Cushing syndrome, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for similar conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Lynnette K Nieman, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Raven N McGlotten, R.N.
- Email: mcglottenr@mail.nih.gov
- Phone: (301) 827-0190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ACTH, Cushing's Syndrome, DOTATATE, Hypercortisolism