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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01221896
Other study ID # choline2010-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 14, 2010
Last updated October 14, 2010
Start date January 2011

Study information

Verified date October 2010
Source Hadassah Medical Organization
Contact Marina Orevi, MD
Phone 0508946211
Email marinaor@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Elevation of a calcium and parathyroid hormone in the serum

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
C11-Choline PET/CT


Locations

Country Name City State
Israel Hadassah Hebrew University Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved localization of a parathyroid adenoma
Secondary Facilitation of detection of the parathyroid adenoma at surgery
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