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Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Primary Purpose

Primary Hyperparathyroidism, Hypercalcemia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcitonin
Sponsored by
ProMedica Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ProMedica Toledo HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity of SPECT-CT
conversion rate from non-localizing to localizing exam

Secondary Outcome Measures

Surgical Approach
Rate of minimally-invasive surgery compared to four gland exploration
Success Rate
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism

Full Information

First Posted
April 30, 2019
Last Updated
August 26, 2019
Sponsor
ProMedica Health System
Collaborators
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03935984
Brief Title
Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Official Title
Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ProMedica Health System
Collaborators
University of Toledo Health Science Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism, Hypercalcemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Calcitonin
Other Intervention Name(s)
Miacalcin
Intervention Description
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Primary Outcome Measure Information:
Title
Sensitivity of SPECT-CT
Description
conversion rate from non-localizing to localizing exam
Time Frame
one year
Secondary Outcome Measure Information:
Title
Surgical Approach
Description
Rate of minimally-invasive surgery compared to four gland exploration
Time Frame
6 months
Title
Success Rate
Description
Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
Time Frame
6 months from surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Redfern, PhD
Phone
419-291-7517
Email
roberta.redfern@promedica.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Seegert, MSN
Phone
419-291-7709
Email
sara.seegert@promedica.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Jaume, MD
Organizational Affiliation
University of Toledo College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Redfern, PhD
Phone
419-291-7517
Email
roberta.redfern@promedica.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

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