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18F-Fluorocholine for the Detection of Parathyroid Adenomas

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ClinicalTrials.gov Identifier: NCT03764007
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Primary Drug: Fluorocholine PET Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluorocholine for the Detection of Parathyroid Adenomas
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Fluorocholine PET arm
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Drug: Fluorocholine PET
Imaging study using PET after the injection of the fluorocholine radio tracer




Primary Outcome Measures :
  1. Sensitivity for the detection of the abnormal parathyroid adenoma. [ Time Frame: Through time of parathyroidectomy, an average of 1 year ]
    Sensitivity of imaging in comparison to pathology at surgery. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biochemically proven hyperparathyroidism and an indication for surgery
  • Age ≥ 13 years
  • Karnofsky performance status of > 50 (or ECOG/WHO equivalent).
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
  • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
  • Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
  • 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): NCT03764007


Contacts
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Contact: Maya Aslam maya.aslam@ucsf.edu

Locations
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United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Thomas Hope, MD       thomas.hope@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Insoo Soo, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03764007     History of Changes
Other Study ID Numbers: 16-19297
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
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

Keywords provided by University of California, San Francisco:
Positron emission tomography

Additional relevant MeSH terms:
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Adenoma
Hyperparathyroidism
Parathyroid Neoplasms
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Parathyroid Hormone
Choline
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents