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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02432599
Acronym
APACH1
Enrollment
28
Registered
2015-05-04
Start date
2015-03-31
Completion date
2017-02-28
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperparathyroidism

Keywords

F18-choline

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.

Interventions

RADIATIONF18-choline PET examination

F18-choline PET examination will be performed before surgery

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity (ability to identify and visualize the parathyroid adenoma)Up to 2 monthsSensitivity 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026