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Trial record 3 of 246 for:    CALCITONIN SALMON

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03935984
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : August 29, 2019
University of Toledo Health Science Campus
Information provided by (Responsible Party):
Juan Jaume, ProMedica Health System

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
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
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 1, 2021

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 Name: Miacalcin

Primary Outcome Measures :
  1. Sensitivity of SPECT-CT [ Time Frame: one year ]
    conversion rate from non-localizing to localizing exam

Secondary Outcome Measures :
  1. Surgical Approach [ Time Frame: 6 months ]
    Rate of minimally-invasive surgery compared to four gland exploration

  2. Success Rate [ Time Frame: 6 months from surgery ]
    Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03935984

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Contact: Roberta Redfern, PhD 419-291-7517
Contact: Sara Seegert, MSN 419-291-7709

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United States, Ohio
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Roberta Redfern, PhD    419-291-7517   
Sponsors and Collaborators
ProMedica Health System
University of Toledo Health Science Campus
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Principal Investigator: Juan Jaume, MD University of Toledo College of Medicine

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Responsible Party: Juan Jaume, Principal Investigator, ProMedica Health System Identifier: NCT03935984    
Other Study ID Numbers: 19-018
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Salmon calcitonin
Calcitonin Gene-Related Peptide
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents