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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-CH-0028

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

DOTATATE;
Cushing's Syndrome;
Hypercortisolism

Recruitment Keyword(s)

None

Condition(s)

ACTH;
Cushing's Syndrome

Investigational Drug(s)

18F-DOPA
68Ga-DOTATATE

Investigational Device(s)

None

Intervention(s)

Radiation: DOTATATE PET-CT
Radiation: F-DOPA PET CT
Radiation: CT scan
Diagnostic Test: Routine MRI scan
Diagnostic Test: Gated MRI scan
Drug: 68Ga-DOTATATE
Drug: 18F-DOPA

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lynnette K. Nieman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CRC BG RM 1-3121
10 CENTER DR
BETHESDA MD 20892
(301) 496-8935
niemanl@mail.nih.gov

Raven N. McGlotten, R.N.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
CRC/1-3121
10 Center Drive
Bethesda, Maryland 20892
(301) 827-0190
mcglottenr@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02019706

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