RECRUITING

99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT

Official Title

Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT

Quick Facts

Study Start:2023-09-27

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05891769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone) 2. Negative or equivocal 99mTc Sestamibi SPECT/CT 3. Able to provide written consent 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN 6. Karnofsky performance status of \>50 (or ECOG/WHO equivalent) 7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.	1. Less than 18 years old at the time of radiotracer administration 2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN 3. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome

Inclusion Criteria

Exclusion Criteria

1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
2. Negative or equivocal 99mTc Sestamibi SPECT/CT
3. Able to provide written consent
4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
6. Karnofsky performance status of \>50 (or ECOG/WHO equivalent)
7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

1. Less than 18 years old at the time of radiotracer administration
2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
3. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome

Contacts and Locations

Study Contact

Andrea Otte, DPT

CONTACT

650-736-4183

anotte@stanford.edu

Principal Investigator

Andrei Iagaru, MD

STUDY_DIRECTOR

Stanford University

Study Locations (Sites)

Stanford Hospital and Clinics

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Andrei Iagaru

Andrei Iagaru, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-27

Study Completion Date2027-07-01

Study Record Updates

Study Start Date2023-09-27

Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

Parathyroid Adenoma