Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome
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|ClinicalTrials.gov Identifier: NCT02019706|
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : March 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|ACTH Cushing's Syndrome||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||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome|
|Actual Study Start Date :||February 12, 2014|
|Estimated Primary Completion Date :||December 31, 2030|
|Estimated Study Completion Date :||December 31, 2030|
All subjects will be imaged
Radiation: DOTATATE PET-CT
Radiation: F-DOPA PET CT
Radiation: CT scan
routine CT scan
Diagnostic Test: Routine MRI scan
routine 1.5 or 3T MRI scan
Diagnostic Test: Gated MRI scan
Cardiac gated MRI scan
- Which imaging technique best detects ectopic ACTH-producing tumors [ Time Frame: 6-12 months ]Subjects will be imaged every 6-12 months until tumor is found
- Is there a combination of tests with optimal diagnostic accuracy? [ Time Frame: 6-12 months ]subjects will be imaged every 6-12 months until tumor is found
- Is there a correlation between F-DOPA or DOTATATE uptake and type of tumor, size and proliferative activity [ Time Frame: Ongoing ]
- Number lesions detected by gated chest MRI vs. routine MRI [ Time Frame: Ongoing ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA:
- Adults with possible ectopic Cushing syndrome
- Age 18-80
- Patients must be willing to return to NIH for follow-up studies.
- Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) prior to each MRI or study involving radiation, unless they have a history of hysterectomy and/or bilateral oophorectomy.
- Children (age less than 18) are excluded. Because ectopic ACTH secretion is rare in this age group, the likelihood of benefit is less and does not balance the risk of radiation.
- Very elderly patients (> 90 years)
- For the mifepristone studies only: Patients taking medications that alter CYP3A4 activity will not be eligible for the mifepristone study, since this P450 system metabolizes mifepristone. Patients with hypokalemia (K < 3.5 mEq/L), despite medical therapy with replacement or mineralocorticoid antagonists will also be excluded from the mifepristone studies. Such patients may participate in other components of the protocol. Medications affecting CYP3A4 may be adjusted to allow participation in the mifepristone component, with a one week washout period.
- The presence of severe active infection.
- clinically significantly impaired cardiovascular (e.g. history of abnormally low ejection fraction, the presence of moderate pulmonary fluid overload, and/or blood pressure over 190/100), 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.
- impaired mental capacity or markedly abnormal psychiatric condition that precludes informed consent.
- 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 450 ml.
- known allergy to [(111)In-DTPA-D-Phe]-pentetreotide or other somatostatin analogues.
- strong evidence for Cushing s disease. This includes those with a central to peripheral ACTH gradient during IPSS or a lesion on pituitary MRI. We anticipate that these exclusion criteria will increase the ratio of patients with ectopic ACTH syndrome to those with Cushing s disease from the usual 1: 8 to 1: 2, thus we would accrue 3 patients to identify one with ectopic ACTH secretion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019706
|Contact: Raven N McGlotten, R.N.||(301) firstname.lastname@example.org|
|Contact: Lynnette K Nieman, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Lynnette K Nieman, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Responsible Party:||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Other Study ID Numbers:||
|First Posted:||December 24, 2013 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 9, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.On request, IPD related to a publication will be made available.|
Clinical Study Report (CSR)
|Time Frame:||Start at the time of publication, for five years unless the study investigators leave NIH|
|Access Criteria:||The PI will review requests and will provide data to investigators who wish to perform meta-analysis with other manuscript results. Data will be provided as an anonymized excel spread sheet.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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