Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
NCT ID: NCT03935984
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
37 participants
INTERVENTIONAL
2019-05-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment Group
All subjects in this arm will be treated with calcitonin 200IU 2x per day for 2 days, then 1x on day of SPECT-CT imaging
Calcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Interventions
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Calcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Toledo Health Science Campus
OTHER
Joseph Sferra
OTHER
Responsible Party
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Joseph Sferra
Chief of Surgery
Principal Investigators
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Joseph Sferra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toledo College of Medicine
Locations
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ProMedica Toledo Hospital
Toledo, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-018
Identifier Type: -
Identifier Source: org_study_id
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