NCT00001277 · STUDY IN CONTEXT

Studies of Elevated Parathyroid Activity

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The 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.

Source null

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primary · POSTED

For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA

Imaging was only conducted in the "DOTATATE and F-DOPA" Arm/Group and therefore results are only reported for this arm

→

primary · POSTED

The total number of lesions identified by each imaging modality

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

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-head-and-neck-neoplasm
nct id: NCT00001277
trial label: Studies of Elevated Parathyroid Activity
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0000
source section id
NCT00001277-om-0000
source outcome index
0
endpoint
Type of Hyperparathyroidism
endpoint definition
The 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.
time origin
First year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0001
source section id
NCT00001277-om-0001
source outcome index
1
endpoint
Organs With Identified Lesions
endpoint definition
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
time origin
Days 1-6
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Imaging was only conducted in the "DOTATATE and F-DOPA" Arm/Group and therefore results are only reported for this arm
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0002
source section id
NCT00001277-om-0002
source outcome index
2
endpoint
Number of Lesions Identified
endpoint definition
The total number of lesions identified by each imaging modality
time origin
Days 1-6
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0000
arm key
OG000
arm label
Primary Hyperparathyroidism - Incomplete Data
regimen
Patients with confirmed or suspected primary hyperparathyroidism or complications who are missing age and other baseline data because of changes in data management system
analyzed count
634
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00001277-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0000
arm key
OG001
arm label
Primary Hyperparathyroidism
regimen
Patients with confirmed or suspected primary hyperparathyroidism or complications
analyzed count
900
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00001277-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0000
arm key
OG002
arm label
DOTATATE and F-DOPA
regimen
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.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00001277-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0001
arm key
OG000
arm label
DOTATATE and F-DOPA
regimen
Patients who received both DOTATATE and F-DOPA scans
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00001277-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
outcome key
om-0002
arm key
OG000
arm label
DOTATATE and F-DOPA
regimen
Patients who received both DOTATATE and F-DOPA scans
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00001277-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
harm key
EG000
source section id
NCT00001277-ae
event group key
EG000
event group label
Primary Hyperparathyroidism - Incomplete Data
serious affected
0
serious at risk
634
other affected
0
other at risk
634
frequency threshold
5
collection period
3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
harm key
EG001
source section id
NCT00001277-ae
event group key
EG001
event group label
Primary Hyperparathyroidism
serious affected
0
serious at risk
900
other affected
0
other at risk
900
frequency threshold
5
collection period
3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00001277
harm key
EG002
source section id
NCT00001277-ae
event group key
EG002
event group label
DOTATATE and F-DOPA
serious affected
0
serious at risk
19
other affected
1
other at risk
19
frequency threshold
5
collection period
3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice