Trial Outcomes & Findings for New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome (NCT NCT00001849)
NCT ID: NCT00001849
Last Updated: 2021-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
six months or less
Results posted on
2021-04-14
Participant Flow
Patients were recruited based on physician referral to the NIH Clinical Center from 4/1999 to 12/2015. The first participant enrolled on 5/20/99 and the last participant enrolled on 11/19/15. Of 95 enrolled participants, 68 met inclusion criteria and underwent imaging studies.
27 patients had biochemical testing consistent with Cushing's disease and were excluded from additional participation.
Unit of analysis: lesions, total body
Participant milestones
| Measure |
Patients With Presumed Ectopic ACTH Secretion
Patients 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.
FDG-PET: Fluorodeoxyglucose (FDG) is a radiolabeled glucose used as a radiotracer in positron emission tomography (PET); FDG-PET was deleted as a required research study in 2004; thereafter used as clinically indicated.
Fluorine-18 dihydroxyphenylalanine (F-DOPA) is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.
CT Scans, MRI scans
|
|---|---|
|
Overall Study
STARTED
|
68 68
|
|
Overall Study
COMPLETED
|
54 54
|
|
Overall Study
NOT COMPLETED
|
14 14
|
Reasons for withdrawal
| Measure |
Patients With Presumed Ectopic ACTH Secretion
Patients 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.
FDG-PET: Fluorodeoxyglucose (FDG) is a radiolabeled glucose used as a radiotracer in positron emission tomography (PET); FDG-PET was deleted as a required research study in 2004; thereafter used as clinically indicated.
Fluorine-18 dihydroxyphenylalanine (F-DOPA) is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.
CT Scans, MRI scans
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
tumor remained occult
|
6
|
Baseline Characteristics
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
Baseline characteristics by cohort
| Measure |
Patients With Presumed Ectopic ACTH Secretion
n=68 Participants
Patients 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.
FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in positron emission tomography; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated.
Fluorine-18 (18F)-DOPA: 18F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.
CT Scans, MRI scans
|
|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
|
Participants with presumed ectopic corticotropin (ACTH) syndrome
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six months or lessPopulation: Tumors identified by specific imaging modality in each patient
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.
Outcome measures
| Measure |
CT Scan Results
n=69 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
CT Scans of chest, abdomen, neck and/or pelvis are used.
|
Magnetic Resonance Imaging (MRI) Results
n=55 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
MRI scans of chest, abdomen, neck, head, and/or pelvis obtained at 1.5 Tesla are shown.
|
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Results
n=13 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated.
|
[18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET Results
n=24 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.
|
Standard Dose Pentetreotide Results
n=57 lesions on imaging
Patients 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 standard dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.
|
High Dose (18 mCi) Pentetreotide Results
n=22 lesions on imaging
Patients 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.
|
|---|---|---|---|---|---|---|
|
Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients
|
96.3 percentage of patients
Interval 87.7 to 99.0
|
77.1 percentage of patients
Interval 61.2 to 85.1
|
66.7 percentage of patients
Interval 35.4 to 87.9
|
100 percentage of patients
Interval 85.7 to 100.0
|
45.1 percentage of patients
Interval 32.3 to 58.6
|
42.9 percentage of patients
Interval 24.5 to 63.5
|
PRIMARY outcome
Timeframe: six months or lessPopulation: Tumors identified by specific imaging modality by lesions
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.
Outcome measures
| Measure |
CT Scan Results
n=69 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
CT Scans of chest, abdomen, neck and/or pelvis are used.
|
Magnetic Resonance Imaging (MRI) Results
n=55 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
MRI scans of chest, abdomen, neck, head, and/or pelvis obtained at 1.5 Tesla are shown.
|
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Results
n=13 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
FDG-PET: FDG is a radiolabeled glucose used as a radiotracer in; FDG-PET deleted as required research study in 2004; thereafter used as clinically indicated.
|
[18F]-L-3,4-dihydroxyphenylalanine (18F-DOPA) PET Results
n=24 lesions on imaging
Patients receive various types of radiologic or nuclear medicine scans to identify tumor
18F-DOPA: F-DOPA is a radiolabeled amino acid used as a radiotracer in positron emission tomography. F-DOPA scans are limited to 3 over the course of the study.
|
Standard Dose Pentetreotide Results
n=57 lesions on imaging
Patients 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 standard dose (6mCi) was negative and scheduling was available. High doses limited to 3 over the course of the study.
|
High Dose (18 mCi) Pentetreotide Results
n=22 lesions on imaging
Patients 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.
|
|---|---|---|---|---|---|---|
|
Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Specific Lesions
|
75.4 percentage of lesions
Interval 64.0 to 84.0
|
67.3 percentage of lesions
Interval 53.4 to 77.8
|
46.2 percentage of lesions
Interval 23.2 to 71.0
|
95.8 percentage of lesions
Interval 79.8 to 99.3
|
40.4 percentage of lesions
Interval 28.6 to 53.3
|
40.9 percentage of lesions
Interval 23.3 to 61.3
|
Adverse Events
Patients With Cushing Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place