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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Dec 21, 2013

Keywords

ClinConnect Summary

This clinical trial is investigating new imaging techniques to locate the source of ectopic Cushing syndrome, a condition where the body produces too much cortisol due to an abnormal production of a hormone called ACTH. Traditional imaging methods often struggle to identify the source of this hormone in about half of the patients. The study will use two advanced imaging methods, 68Ga-DOTATATE PET and 18F-DOPA PET, which may offer better results by detecting changes in the body’s chemistry rather than just looking at its structure.

To participate in this trial, you need to be between 18 and 90 years old and have a medical history suggesting ectopic Cushing syndrome. Women who can become pregnant must agree to use effective birth control during the study. Participants will undergo PET scans to help find the source of the hormone production. It's important to note that certain health conditions and factors, like pregnancy or significant heart issues, may prevent individuals from joining the study. Overall, this research aims to improve how we identify and treat patients with this challenging condition.

Gender

ALL

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.