Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Sponsor

ProMedica Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT03935984

Collaborator

University of Toledo Health Science Campus (Other)

Enrollment

Location

Arm

28.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism Hypercalcemia	Drug: Calcitonin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism

Actual Study Start Date :

May 29, 2019

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Calcitonin Treatment with calcitonin to lower high calcium levels prior to reimaging exam Other Names: Miacalcin

Arm

Intervention/Treatment

Experimental: 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

Drug: Calcitonin

Treatment with calcitonin to lower high calcium levels prior to reimaging exam

Other Names:

Miacalcin

Outcome Measures

Primary Outcome Measures

Sensitivity of SPECT-CT [one year]
conversion rate from non-localizing to localizing exam

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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