Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
APACH1
1 other identifier
interventional
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJanuary 4, 2018
August 1, 2016
1.9 years
April 29, 2015
January 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 2 months
Study Arms (1)
F18-choline PET
EXPERIMENTALF18-choline PET examination will be performed before surgery
Interventions
F18-choline PET examination will be performed before surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU
Caen, 14000, France
Centre François Baclesse
Caen, 14076, France
Related Publications (1)
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.
PMID: 29270788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 4, 2015
Study Start
March 1, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
January 4, 2018
Record last verified: 2016-08