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

NCT01221896 | Unknown

• 1 other identifier: choline2010-HMO-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Keywords

Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.

Outcome Measures

Primary Outcomes (1)

• Improved localization of a parathyroid adenoma

Secondary Outcomes (1)

• Facilitation of detection of the parathyroid adenoma at surgery

Study Arms (1)

Hyperparathyroidism

Patients with hyperparathyroidism, prior to surgery.

Procedure: C11-Choline PET/CT

Interventions

C11-Choline PET/CT PROCEDURE

Hyperparathyroidism

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with elevated PTH in search of a PTA

You may qualify if:

• Elevation of a calcium and parathyroid hormone in the serum

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Marina Orevi, MD

CONTACT

0508946211; marinaor@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

IL (1)