Back to resultsInterest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas (APACH1)
Primary Purpose
Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
F18-choline PET examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperparathyroidism focused on measuring F18-choline
Eligibility 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
Sites / Locations
- CHU
- Centre François Baclesse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F18-choline PET
Arm Description
F18-choline PET examination will be performed before surgery
Outcomes
Primary Outcome Measures
Sensitivity (ability to identify and visualize the parathyroid adenoma)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02432599
First Posted
April 29, 2015
Last Updated
January 2, 2018
Sponsor
Centre Francois Baclesse
1. Study Identification
Unique Protocol Identification Number
NCT02432599
Brief Title
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Acronym
APACH1
Official Title
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
F18-choline
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F18-choline PET
Arm Type
Experimental
Arm Description
F18-choline PET examination will be performed before surgery
Intervention Type
Radiation
Intervention Name(s)
F18-choline PET examination
Intervention Description
F18-choline PET examination will be performed before surgery
Primary Outcome Measure Information:
Title
Sensitivity (ability to identify and visualize the parathyroid adenoma)
Description
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
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29270788
Citation
Quak E, Blanchard D, Houdu B, Le Roux Y, Ciappuccini R, Lireux B, de Raucourt D, Grellard JM, Licaj I, Bardet S, Reznik Y, Clarisse B, Aide N. F18-choline PET/CT guided surgery in primary hyperparathyroidism when ultrasound and MIBI SPECT/CT are negative or inconclusive: the APACH1 study. Eur J Nucl Med Mol Imaging. 2018 Apr;45(4):658-666. doi: 10.1007/s00259-017-3911-1. Epub 2017 Dec 22.
Results Reference
derived
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Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
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