New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome

NCTNCT00001849Other id990055Other id99-CH-0055

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.
Names Octreotide, does not test it. It appears in the summary.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 95 participants (actual)
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Nih
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 20 May 1999
Primary completion: 26 Apr 2019
Completion: 26 Apr 2019
First posted: 4 Nov 1999 (estimated)
Last update posted: 14 Apr 2021
Conditions: Cushing Syndrome · Endocrine Disease

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20002005201020152020

Ph 2
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
NCT00001849
20 May 1999 to 26 Apr 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.

Interventions

PentetreotideDrug
18F-DOPADrug
CT scanDevice
MRIDevice
18-FDGDrug

Arms1

Experimental
Patients with Cushing Syndrome
Patients receive various types of radiologic or nuclear medicine scans to identify tumor

Primary outcomes2

Outcomes the sponsor listed as primary.

Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients
Time frame · six months or less
Registry description
The percentage of patients in whom imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or in which imaging identified a recurrence at a site of previous resection.
Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions
Time frame · six months or less
Registry description
The percentage of lesions for which imaging correctly identified an ACTH-secreting non-pituitary tumor within six months of resection or for which imaging identified a recurrence at a site of previous resection.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· six months or less

Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients

Group	Value (percentage of patients)
CT Scan Results	96.3
Magnetic Resonance Imaging (MRI) Results	77.1
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Results	66.7
[18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET Results	100
Standard Dose Pentetreotide Results	45.1
High Dose (18 mCi) Pentetreotide Results	42.9

Primary outcomeNumber· six months or less

Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions

Group	Value (percentage of lesions)
CT Scan Results	75.4
MRI Results	67.3
FDG-PET Results	46.2
F-DOPA PET Results	95.8
Standard Dose Pentetreotide Results	40.4
High Dose (18 mCi) Octreotide Results	40.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Patients With Cushing SyndromePatients receive various types of radiologic or nuclear medicine scans to identify tumor Pentetreotide: Binds primarily to the somatostatin receptors subtypes (sst) 2 and 5. A high dose (18mCi) was used if the conventional dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study. 18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. Limited to 3 doses over the course of the study. CT scan: CT scan of chest, abdomen, neck and /or pelvis MRI: MRI scan of head/pituitary, chest, abdomen, neck and /or pelvis 18-FDG: FDG PET scan of body	4 / 68	0 / 65	0 / 65

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

* INCLUSION CRITERIA: All eligible patients are invited to participate in this protocol. Patients are adults with possible ectopic Cushing syndrome. Since both men and women are affected with ectopic Cushing syndrome, both sexes are studied. All ethnic and racial groups are at risk and will be included. Patients must be willing to return to the National Institutes of Health (NIH) Clinical Center for follow-up studies. EXCLUSION CRITERIA: Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) unless they have a history of hysterectomy. Children (age less than18) 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. Patients taking medications that alter CYP3A4 activity will not be eligible for the mifepristone study, since this P450 system metabolizes mifepristone. Such participants would receive a clinical high dose (18 mCi) octreoscan (H-OCT) instead, if the standard 6 mCi octreoscan (L-OCT) was negative. Patients with hypokalemia (K \< 3.5 milliequivalent (mEq)/L) despite medical therapy with replacement or mineralocorticoid antagonists will also be excluded from the mifepristone studies. 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 or leg edema, and blood pressure over 190/100), abnormal coagulation (partial thromboplastin time or prothrombin time elevated by 30 percent above the normal values), hematopoietic (hematocrit less than 30 percent, hemoglobin below 10 g/dl, white count below 3000 K/microliter (UL), and platelets below 100,000 K/mm(3)), hepatic (liver enzymes elevated by 3-fold above normal values) or renal function (plasma creatinine level over 2.0). * impaired mental capacity or markedly abnormal psychiatric evaluation 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, of greater than 450 ml. * known allergy to 111-indium pentetreotide or other somatostatin analogues. * strong evidence for Cushing disease. This includes those with positive inferior petrosal sinus sampling or a lesion on pituitary MRI.

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