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Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas (APACH1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432599
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:
The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Radiation: F18-choline PET examination Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Study Start Date : March 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F18-choline PET
F18-choline PET examination will be performed before surgery
Radiation: F18-choline PET examination
F18-choline PET examination will be performed before surgery




Primary Outcome Measures :
  1. Sensitivity (ability to identify and visualize the parathyroid adenoma) [ Time Frame: Up to 2 months ]
    Sensitivity of PET-CT with F18-choline (FCH) to identify and visualize the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory parathyroid scintigraphy MIBI and cervical ultrasound



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:

  • Patient aged 18 years or more;
  • Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
  • Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
  • Affiliate to a social security system;
  • Patient written informed consent.

Exclusion Criteria:

  • Patient deprived of liberty, under guardianship;
  • Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
  • Pregnant or breastfeeding

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): NCT02432599


Locations
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France
CHU
Caen, France, 14000
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02432599    
Other Study ID Numbers: APACH1
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: August 2016
Keywords provided by Centre Francois Baclesse:
F18-choline
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents