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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02432599
Other study ID # APACH1
Secondary ID
Status Completed
Phase Phase 2
First received April 29, 2015
Last updated January 2, 2018
Start date March 2015
Est. completion date February 2017

Study information

Verified date August 2016
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
F18-choline PET examination
F18-choline PET examination will be performed before surgery

Locations

Country Name City State
France Centre François Baclesse Caen
France CHU Caen

Sponsors (1)

Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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