Status:
RECRUITING
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Lead Sponsor:
Joseph Sferra
Collaborating Sponsors:
University of Toledo Health Science Campus
Conditions:
Primary Hyperparathyroidism
Hypercalcemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 leve...
Eligibility Criteria
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
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03935984
Start Date
May 29 2019
End Date
December 31 2026
Last Update
September 19 2024
Active Locations (1)
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1
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606