Primary Hyperparathyroidism, Hypercalcemia
Conditions
Brief summary
Patients with biochemically confirmed primary hyperparathyroidism and non-localizing SPECT-CT exam within the past year will be included. Subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. The goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of SPECT-CT to localize parathyroid adenoma.
Interventions
DRUGCalcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Sponsors
University of Toledo Health Science Campus
Joseph Sferra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary hyperparathyroidism * Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study * Patient desires surgical intervention for treatment of PHPT * No contraindications to 99mTC-Sestamibi * No contraindications to treatment with calcitonin * Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL * Patient consents to participate and undergo second SPECT-CT for purposes of research
Exclusion criteria
* Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary * Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT * Allergy to calcitonin * Hypocalcemia (contraindication to calcitonin) * Vitamin D deficiency (contraindication to calcitonin) * Previous treatment with radioactive iodine * New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan) * Lithium exposure within one year of SPECT-CT (index and research scans) * Secondary hyperparathyroidism * Benign familial hypocalciuric hypercalcemia * Known malignancy, particularly multiple endocrine neoplasia * New prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan) * Currently taking calcium channel blockers * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of SPECT-CT | one year | conversion rate from non-localizing to localizing exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Approach | 6 months | Rate of minimally-invasive surgery compared to four gland exploration |
| Success Rate | 6 months from surgery | Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism |
Countries
United States
Contacts
Primary ContactLeah Stevenson, MS
Backup ContactDawn Muskiewicz, MS
Outcome results
None listed