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

This study is not yet open for participant recruitment.
Verified October 2010 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01221896
First received: October 14, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention
Hyperparathyroidism
 Procedure: C11-Choline PET/CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Improved localization of a parathyroid adenoma

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

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hyperparathyroidism
Patients with hyperparathyroidism, prior to surgery.
 Procedure: C11-Choline PET/CT

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with elevated PTH in search of a PTA

Criteria

Inclusion Criteria:

  • Elevation of a calcium and parathyroid hormone in the serum
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221896

Contacts
Contact: Marina Orevi, MD 0508946211 marinaor@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Marina Orevi, MD     0508946211     marinaor@hadassah.org.il    
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01221896     History of Changes
Other Study ID Numbers: choline2010-HMO-CTIL
Study First Received: October 14, 2010
Last Updated: October 14, 2010
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Choline
Lipotropic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013