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Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

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ClinicalTrials.gov Identifier: NCT03935984
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03935984


Contacts
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Contact: Roberta Redfern, PhD 419-291-7517 roberta.redfern@promedica.org
Contact: Sara Seegert, MSN 419-291-7709 sara.seegert@promedica.org

Locations
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United States, Ohio
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Roberta Redfern, PhD    419-291-7517    roberta.redfern@promedica.org   
Sponsors and Collaborators
ProMedica Health System
University of Toledo Health Science Campus
Investigators
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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
ClinicalTrials.gov Identifier: NCT03935984     History of Changes
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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Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents