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

Hyperparathyroidism Clinical Trial

— APACH1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432599
• Other study ID #: APACH1
• 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
• 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

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Parathyroid Neoplasms

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