This study is currently recruiting participants.
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)
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
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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.
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.
Principal Investigator
Referral Contact
For more information: