18F-Fluorocholine for the Detection of Parathyroid Adenomas

NCT ID: NCT03764007

Last Updated: 2021-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-21

Study Completion Date

2021-05-31

Brief Summary

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The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Detailed Description

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Conditions

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Hyperparathyroidism, Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-Fluorocholine PET

Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Group Type EXPERIMENTAL

18F-Fluorocholine

Intervention Type DRUG

Given intravenously

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities

Interventions

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18F-Fluorocholine

Given intravenously

Intervention Type DRUG

Positron Emission Tomography (PET)

Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities

Intervention Type PROCEDURE

Other Intervention Names

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Fluorocholine PET

Eligibility Criteria

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Inclusion Criteria

* Biochemically proven hyperparathyroidism and an indication for surgery
* Age \>= 13 years old
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
* Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Pregnancy.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Hope

OTHER

Sponsor Role lead

Responsible Party

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Thomas Hope

Associate Professor, Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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16-19297

Identifier Type: -

Identifier Source: org_study_id