A Phase 2 interventional study of 68Ga-Dotatate and 18F-DOPA in Hyperparathyroidism, Hypercalcemia and Parathyroid Neoplasm, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Diagnostic
Observational Phase: Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperparathyroidism and to evaluate and improve methods for diagnosis and treatment. Patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions, such as parathyroid tumors, will also be selected.
Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing.
Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body.
Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with multiple endocrine neoplasia type 1 (MEN1) will have 68Gallium-Dotatate Positron Emission Tomography (PET) - Computed Tomography (CT), 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared.
Observational: Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment. The principal diagnostic components are calcium in serum and urine, parathyroid hormone in serum, and mutation tests on germline or tumor DNA. Patients with moderate to severe primary hyperparathyroidism will be treated. Treatment will be mainly by parathyroidectomy. Other options are medications or no intervention. Patients with a hyperparathyroid syndrome may be managed for their extraparathyroid features. Preoperative testing to localize parathyroid neoplasm(s) will be used usually and with more extended methods in cases with prior neck surgery. Preoperative tumor localization tests will be selected according to clinical indications from the following: ultrasound, technetium-thallium scan, computerized tomography, magnetic resonance imaging, fine needle aspiration for parathyroid hormone assay, selective arteriogram, selective venous catheterization for parathyroid hormone assay. Options for management of postoperative hypocalcemia include calcium, vitamin D analogs, parathyroid autografts and synthetic parathyroid hormone. Research specimens may consist of blood or tumors.
Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with MEN1 will have 68Ga-Dotatate PET/CT, 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared.
110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.
This study's enrollment of 1,553 is above the median of 53 across 67 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with confirmed or suspected primary hyperparathyroidism or complications
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
Drug: 68Ga-Dotatate · Drug: 18F-DOPA
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 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
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 frame: First year
Organs With Identified Lesions
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
Time frame: Days 1-6
Number of Lesions Identified
The total number of lesions identified by each imaging modality
Time frame: Days 1-6
| Milestone | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA |
|---|---|---|---|
| Started | 634 | 900 | 19 |
| Completed | 634 | 900 | 16 |
| Not completed | 0 | 0 | 3 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: The tracer f-dopa did not meet quality control standards | 0 | 0 | 2 |
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.
| Participants | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA |
|---|---|---|---|
| MEN1 | 90 | 276 | 19 |
| Other familial | 61 | 116 | 0 |
| Sporadic | 456 | 419 | 0 |
| Unknown - insufficient information | 27 | 89 | 0 |
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
| Participants | DOTATATE and F-DOPA |
|---|---|
| All locations — No lesions by Dotatate or F-DOPA | 1 |
| All locations — Lesions by F-DOPA only | 0 |
| All locations — Lesions by Dotatate only | 7 |
| All locations — Lesions by Both | 8 |
| Lung — No lesions by Dotatate or F-DOPA | 13 |
| Lung — Lesions by F-DOPA only | 0 |
| Lung — Lesions by Dotatate only | 0 |
| Lung — Lesions by Both | 3 |
| Gastrointestinal — No lesions by Dotatate or F-DOPA | 12 |
| Gastrointestinal — Lesions by F-DOPA only | 0 |
| Gastrointestinal — Lesions by Dotatate only | 3 |
| Gastrointestinal — Lesions by Both | 1 |
| Pancreas — No lesions by Dotatate or F-DOPA | 3 |
| Pancreas — Lesions by F-DOPA only | 0 |
| Pancreas — Lesions by Dotatate only | 9 |
| Pancreas — Lesions by Both | 4 |
| Duodenum — No lesions by Dotatate or F-DOPA | 9 |
| Duodenum — Lesions by F-DOPA only | 0 |
| Duodenum — Lesions by Dotatate only | 6 |
| Duodenum — Lesions by Both | 1 |
| Liver — No lesions by Dotatate or F-DOPA | 11 |
| Liver — Lesions by F-DOPA only | 0 |
| Liver — Lesions by Dotatate only | 3 |
| Liver — Lesions by Both | 2 |
| Adrenal — No lesions by Dotatate or F-DOPA | 12 |
| Adrenal — Lesions by F-DOPA only | 1 |
| Adrenal — Lesions by Dotatate only | 3 |
| Adrenal — Lesions by Both | 0 |
| Lymph nodes — No lesions by Dotatate or F-DOPA | 7 |
| Lymph nodes — Lesions by F-DOPA only | 0 |
| Lymph nodes — Lesions by Dotatate only | 4 |
| Lymph nodes — Lesions by Both | 5 |
The total number of lesions identified by each imaging modality
| Lesions | DOTATATE and F-DOPA |
|---|---|
| No lesions by Dotatate or F-DOPA | 44 |
| Lesions by F-DOPA only | 1 |
| Lesions by Dotatate only | 67 |
| Lesions by Both | 22 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Hyperparathyroidism - Incomplete Data | 0/634 (0%) | 0/634 (0%) | 0/634 (0%) |
| Primary Hyperparathyroidism | 0/900 (0%) | 0/900 (0%) | 0/900 (0%) |
| DOTATATE and F-DOPA | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| Event | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | — | 0/900 | 1/19 |
Age is not available for 634 participants in the primary hyperparathyroidism arm because the necessary records are not in the current computer system
| Age, Continuous(Years) | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA | Total |
|---|---|---|---|---|
| Median | — | 48 (36 to 60) | 54 (38 to 64) | 48 (36 to 60) |
| Sex: Female, Male(Participants) | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA | Total |
|---|---|---|---|---|
| Female | 409 | 582 | 6 | 997 |
| Male | 225 | 318 | 13 | 556 |
| Ethnicity (NIH/OMB)(Participants) | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 0 | 0 | 14 | 14 |
| Unknown or Not Reported | 634 | 900 | 4 | 1538 |
| Race (NIH/OMB)(Participants) | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 4 | 0 | 4 |
| Asian | 0 | 25 | 0 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 0 | 100 | 1 | 101 |
| White | 0 | 719 | 16 | 735 |
| More than one race | 0 | 13 | 0 | 13 |
| Unknown or Not Reported | 634 | 38 | 2 | 674 |
| Region of Enrollment(participants) | Primary Hyperparathyroidism - Incomplete Data | Primary Hyperparathyroidism | DOTATATE and F-DOPA | Total |
|---|---|---|---|---|
| United States | 634 | 900 | 19 | 1553 |
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Studies of the drug tested here: Gallium Ga 68 dotatate
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