Input of C11-Choline PET/CT in Localization of Parathyroid Adenoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01221896
Recruitment Status : Unknown
Verified October 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2010
Last Update Posted : October 15, 2010
Information provided by:
Hadassah Medical Organization

Brief Summary:

The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA).

Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US.

Currently, the conventional technique for localization of a PTA is a dual-isotope scan with Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.

In addition, there is no anatomical imaging and further correlation with US is usually recommended.

In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection, and provides data of higher resolution of functional (PET) and anatomical imaging (CT).

Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of a chest is: 0.3128 - 0.8628rem.

Condition or disease Intervention/treatment
Hyperparathyroidism Procedure: C11-Choline PET/CT

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2011
Estimated Primary Completion Date : January 2014

Group/Cohort Intervention/treatment
Patients with hyperparathyroidism, prior to surgery.
Procedure: C11-Choline PET/CT

Primary Outcome Measures :
  1. Improved localization of a parathyroid adenoma

Secondary Outcome Measures :
  1. Facilitation of detection of the parathyroid adenoma at surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with elevated PTH in search of a PTA

Inclusion Criteria:

  • Elevation of a calcium and parathyroid hormone in the serum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01221896

Contact: Marina Orevi, MD 0508946211

Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Marina Orevi, MD    0508946211   
Sponsors and Collaborators
Hadassah Medical Organization Identifier: NCT01221896     History of Changes
Other Study ID Numbers: choline2010-HMO-CTIL
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by Hadassah Medical Organization:
Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.

Additional relevant MeSH terms:
Parathyroid Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents