Evaluatie van 68Ga-DOTATATE PET/CT, Octreotide en F-DOPA PET-beeldvorming bij patiënten met ectopisch Cushing-syndroom
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Study Description:
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.
Objectives:
Primary Objectives:
- To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, standard CT, and/or standard MRI) has the best sensitivity.
- To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
Secondary Objective:
-To evaluate a potential correlation between 18F-DOPA or 68Ga-DOTATATE uptake and the type of tumor, its size, SSTR expression or proliferative activity.
Exploratory Objectives:
- To evaluate the ability of gated cardiac imaging with CT and MRI to improve the detection of retrocardiac lung lesions.
- To determine whether PET scans at an interval of less than one year localize tumors.
Endpoints:
Primary Endpoint:
-Imaging results and pathology of resected tumors
Secondary Endpoints:
-18F-DOPA or 68Ga-DOTATATE imaging results, tumor pathology, tumor size, proliferative index and SSTR expression.
Exploratory Endpoints:
- Gated cardiac imaging CT and/or MRI; all other imaging results, tumor pathology.
- Imaging results and pathology of resected tumors.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Raven N McGlotten, R.N.
- Telefoonnummer: (301) 827-0190
- E-mail: mcglottenr@mail.nih.gov
Studie Contact Back-up
- Naam: Lynnette K Nieman, M.D.
- Telefoonnummer: (301) 496-8935
- E-mail: niemanl@mail.nih.gov
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892
- Werving
- National Institutes of Health Clinical Center
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Imaging
All subjects will be imaged |
68Ga-DOTATATE PET/CT 68Ga-DOTATATE PET/CT routine CT scan routine 1.5 or 3T MRI scan Cardiac gated MRI scan 68Ga-DOTATATE radioligand 18F-DOPA radioligand |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.
Tijdsspanne: 6-12 months
|
Subjects will be imaged every 6-12 months until tumor is found |
6-12 months
|
|
To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
Tijdsspanne: 6-12 months
|
subjects will be imaged every 6-12 months until tumor is found |
6-12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Om een potentiële correlatie te evalueren tussen de opname van 18F-DOPA of 68Ga-DOTATATE en het type tumor, de grootte ervan, SSTR-expressie of proliferatieve activiteit.
Tijdsspanne: Voortdurende
|
Voortdurende
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Lynnette K Nieman, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 140028
- 14-CH-0028
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
On request, IPD related to a publication will be made available.
IPD-tijdsbestek voor delen
Start at the time of publication, for five years unless the study investigators leave NIH
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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