Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

NCT ID: NCT03935984

Last Updated: 2024-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hyperparathyroidism Hypercalcemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

Calcitonin

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Miacalcin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role collaborator

Joseph Sferra

OTHER

Sponsor Role lead

Responsible Party

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Joseph Sferra

Chief of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leah Stevenson, MS

Role: CONTACT

419-291-3491

Dawn Muskiewicz, MS

Role: CONTACT

419-291-7517

Facility Contacts

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Roberta Redfern, PhD

Role: primary

419-291-7517

Other Identifiers

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19-018

Identifier Type: -

Identifier Source: org_study_id

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