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Completed

NCT Number: NCT02432599

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

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.

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Key information

Conditions

Hyperparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F18-choline PET examination

Radiation

F18-choline PET examination will be performed before surgery

Primary outcomes

  1. Sensitivity (ability to identify and visualize the parathyroid adenoma)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: APACH1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 4, 2015
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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