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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT02019706
• Date of registration: 21/12/2013
• Prospective Registration: Yes
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
• Scientific title: Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
• Date of first enrolment: February 12, 2014
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02019706
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Lynnette K Nieman, M.D.
• Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

• Name: Raven N McGlotten, R.N.

Key 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ACTH

Cushing's Syndrome

Intervention(s)

Drug: 68Ga-DOTATATE

Radiation: CT scan

Radiation: DOTATATE PET-CT

Diagnostic Test: Routine MRI scan

Drug: 18F-DOPA

Diagnostic Test: Gated MRI scan

Radiation: F-DOPA PET CT

Primary Outcome(s)

To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity. [Time Frame: 6-12 months]

To determine if there is a combination of imaging tests with optimal diagnostic accuracy. [Time Frame: 6-12 months]

Secondary Outcome(s)

To evaluate a potential correlation between 18F-DOPA or 68Ga-DOTATATE uptake and the type of tumor, its size, SSTR expression or proliferative activity. [Time Frame: Ongoing]

Secondary ID(s)

14-CH-0028

140028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors