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出境医 / 临床实验 / Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 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 Name: Miacalcin
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE May 29, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Sensitivity of SPECT-CT [ Time Frame: one year ]
conversion rate from non-localizing to localizing exam
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Surgical Approach [ Time Frame: 6 months ]
    Rate of minimally-invasive surgery compared to four gland exploration
  • Success Rate [ Time Frame: 6 months from surgery ]
    Rate of patients in whom surgical intervention was successful in curing hyperparathyroidism
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity
Official Title  ICMJE Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Primary Hyperparathyroidism
  • Hypercalcemia
Intervention  ICMJE Drug: Calcitonin
Treatment with calcitonin to lower high calcium levels prior to reimaging exam
Other Name: Miacalcin
Study Arms  ICMJE 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
Intervention: Drug: Calcitonin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roberta Redfern, PhD 419-291-7517 roberta.redfern@promedica.org
Contact: Sara Seegert, MSN 419-291-7709 sara.seegert@promedica.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935984
Other Study ID Numbers  ICMJE 19-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juan Jaume, ProMedica Health System
Study Sponsor  ICMJE ProMedica Health System
Collaborators  ICMJE University of Toledo Health Science Campus
Investigators  ICMJE
Principal Investigator: Juan Jaume, MD University of Toledo College of Medicine
PRS Account ProMedica Health System
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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