Trial Outcomes & Findings for Studies of Elevated Parathyroid Activity (NCT NCT00001277)
NCT ID: NCT00001277
Last Updated: 2022-06-07
Results Overview
The total number of lesions identified by each imaging modality
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1553 participants
Primary outcome timeframe
Days 1-6
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Primary Hyperparathyroidism - Incomplete Data
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Overall Study
STARTED
|
634
|
900
|
19
|
|
Overall Study
COMPLETED
|
634
|
900
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Primary Hyperparathyroidism - Incomplete Data
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
The tracer F-DOPA did not meet Quality Control Standards
|
0
|
0
|
2
|
Baseline Characteristics
These data are not available because of changes to the data management system. Most were enrolled before the year 2000.
Baseline characteristics by cohort
| Measure |
Primary Hyperparathyroidism - Incomplete Data
n=634 Participants
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
n=900 Participants
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
n=19 Participants
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
Total
n=1553 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
—
|
48 Years
n=900 Participants • These data are not available because of changes to the data management system. Most were enrolled before the year 2000.
|
54 Years
n=19 Participants • These data are not available because of changes to the data management system. Most were enrolled before the year 2000.
|
48 Years
n=919 Participants • These data are not available because of changes to the data management system. Most were enrolled before the year 2000.
|
|
Sex: Female, Male
Female
|
409 Participants
n=634 Participants
|
582 Participants
n=900 Participants
|
6 Participants
n=19 Participants
|
997 Participants
n=1553 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=634 Participants
|
318 Participants
n=900 Participants
|
13 Participants
n=19 Participants
|
556 Participants
n=1553 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=634 Participants
|
0 Participants
n=900 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=1553 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=634 Participants
|
0 Participants
n=900 Participants
|
14 Participants
n=19 Participants
|
14 Participants
n=1553 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
634 Participants
n=634 Participants
|
900 Participants
n=900 Participants
|
4 Participants
n=19 Participants
|
1538 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=634 Participants
|
4 Participants
n=900 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=634 Participants
|
25 Participants
n=900 Participants
|
0 Participants
n=19 Participants
|
25 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=634 Participants
|
1 Participants
n=900 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=634 Participants
|
100 Participants
n=900 Participants
|
1 Participants
n=19 Participants
|
101 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=634 Participants
|
719 Participants
n=900 Participants
|
16 Participants
n=19 Participants
|
735 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=634 Participants
|
13 Participants
n=900 Participants
|
0 Participants
n=19 Participants
|
13 Participants
n=1553 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
634 Participants
n=634 Participants
|
38 Participants
n=900 Participants
|
2 Participants
n=19 Participants
|
674 Participants
n=1553 Participants
|
|
Region of Enrollment
United States
|
634 participants
n=634 Participants
|
900 participants
n=900 Participants
|
19 participants
n=19 Participants
|
1553 participants
n=1553 Participants
|
PRIMARY outcome
Timeframe: First yearThe purpose of this study is to understand the causes of primary hyperparathyroidism, to evaluate and improve methods for diagnosis and treatment, and to provide insight into the mechanisms of normal parathyroid function. Hereditary causes of primary hyperparathyroidism will be characterized. Patients were categorized as follows: 1. MEN1: Diagnosed by demonstration of a germline variant in MEN1 gene or one of the following: a) two of three primary MEN1 manifestations b) one primary MEN1 manifestation with a family member with MEN1. 2. Other familial: Non-MEN1 patients who had a positive family history of hyperparathyroidism suspicious for underlying germline predisposition syndrome. 3. Sporadic: Patients who did not have a positive family history of hyperparathyroidism. 4. Unknown: No data to help categorize the patients in any of the above categories.
Outcome measures
| Measure |
Primary Hyperparathyroidism - Incomplete Data
n=634 Participants
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
n=900 Participants
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
n=19 Participants
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Type of Hyperparathyroidism
MEN1
|
90 Participants
|
276 Participants
|
19 Participants
|
|
Type of Hyperparathyroidism
Other familial
|
61 Participants
|
116 Participants
|
0 Participants
|
|
Type of Hyperparathyroidism
Sporadic
|
456 Participants
|
419 Participants
|
0 Participants
|
|
Type of Hyperparathyroidism
Unknown - insufficient information
|
27 Participants
|
89 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1-6Population: Imaging was only conducted in the "DOTATATE and F-DOPA" Arm/Group and therefore results are only reported for this arm
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
Outcome measures
| Measure |
Primary Hyperparathyroidism - Incomplete Data
n=16 Participants
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Organs With Identified Lesions
All locations · No lesions by Dotatate or F-DOPA
|
1 Participants
|
—
|
—
|
|
Organs With Identified Lesions
All locations · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
All locations · Lesions by Dotatate only
|
7 Participants
|
—
|
—
|
|
Organs With Identified Lesions
All locations · Lesions by Both
|
8 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lung · No lesions by Dotatate or F-DOPA
|
13 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lung · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lung · Lesions by Dotatate only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lung · Lesions by Both
|
3 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Gastrointestinal · No lesions by Dotatate or F-DOPA
|
12 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Gastrointestinal · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Gastrointestinal · Lesions by Dotatate only
|
3 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Gastrointestinal · Lesions by Both
|
1 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Pancreas · No lesions by Dotatate or F-DOPA
|
3 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Pancreas · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Pancreas · Lesions by Dotatate only
|
9 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Pancreas · Lesions by Both
|
4 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Duodenum · No lesions by Dotatate or F-DOPA
|
9 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Duodenum · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Duodenum · Lesions by Dotatate only
|
6 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Duodenum · Lesions by Both
|
1 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Liver · No lesions by Dotatate or F-DOPA
|
11 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Liver · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Liver · Lesions by Dotatate only
|
3 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Liver · Lesions by Both
|
2 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Adrenal · No lesions by Dotatate or F-DOPA
|
12 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Adrenal · Lesions by F-DOPA only
|
1 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Adrenal · Lesions by Dotatate only
|
3 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Adrenal · Lesions by Both
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lymph nodes · No lesions by Dotatate or F-DOPA
|
7 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lymph nodes · Lesions by F-DOPA only
|
0 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lymph nodes · Lesions by Dotatate only
|
4 Participants
|
—
|
—
|
|
Organs With Identified Lesions
Lymph nodes · Lesions by Both
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-6Population: Imaging was only conducted in the "DOTATATE and F-DOPA" Arm/Group and therefore results are only reported for this arm. This outcome is only reported for the 16 patients who had both scans
The total number of lesions identified by each imaging modality
Outcome measures
| Measure |
Primary Hyperparathyroidism - Incomplete Data
n=134 Lesions
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Number of Lesions Identified
Lesions by F-DOPA only
|
1 Lesions
|
—
|
—
|
|
Number of Lesions Identified
No lesions by Dotatate or F-DOPA
|
44 Lesions
|
—
|
—
|
|
Number of Lesions Identified
Lesions by Dotatate only
|
67 Lesions
|
—
|
—
|
|
Number of Lesions Identified
Lesions by Both
|
22 Lesions
|
—
|
—
|
Adverse Events
Primary Hyperparathyroidism - Incomplete Data
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Hyperparathyroidism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DOTATATE and F-DOPA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary Hyperparathyroidism - Incomplete Data
n=634 participants at risk
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
|
Primary Hyperparathyroidism
n=900 participants at risk
Patients with confirmed or suspected primary hyperparathyroidism or complications
|
DOTATATE and F-DOPA
n=19 participants at risk
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
68Ga-Dotatate: 68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA: 18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/634 • 3 months
|
0.00%
0/900 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place