APACH1: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas

• Sponsor: Centre Francois Baclesse (Other)
• Overall Status: Completed
• CT.gov ID: NCT02432599
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Arm: 1
• Duration (Months): 23.1
• Patients Per Site: 14
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism	Radiation: F18-choline PET examination	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F18-choline PET F18-choline PET examination will be performed before surgery	Radiation: F18-choline PET examination; F18-choline PET examination will be performed before surgery

Outcome Measures

Primary Outcome Measures

1. Sensitivity (ability to identify and visualize the parathyroid adenoma) [Up to 2 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU	Caen		France	14000
2	Centre François Baclesse	Caen		France	14076

Sponsors and Collaborators

• Centre Francois Baclesse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Francois Baclesse
• ClinicalTrials.gov Identifier: NCT02432599
• Other Study ID Numbers: APACH1
• First Posted: May 4, 2015
• Last Update Posted: Jan 4, 2018
• Last Verified: Aug 1, 2016

• Keywords provided by Centre Francois Baclesse: F18-choline
• Additional relevant MeSH terms: Adenoma; Parathyroid Neoplasms; Hyperparathyroidism; Choline

Study Results

No Results Posted as of Jan 4, 2018