TheranosticTrials.org

Clinical Trial · NCT01243333

Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors

Overview

This clinical trial studies multi-tracer positron emission tomography in patients with solid tumors. Diagnostic procedures, such as multi-tracer positron emission tomography, may help measure a patient's response to treatment.

Sponsor

University of Utah

Phase

N/A

Contacts

Jeffrey Yap, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01243333

Drug / Compound

FLT

Isotope(s):
Target(s):
  • cytosolic thymidine kinase 1
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Urinalysis less than 4.0 times below or above the upper or lower limit range; urinalysis abnormalities will not preclude the patient from being enrolled and studied
  • Creatinine less than 4.0 times below or above the upper or lower limit range
  • Complete blood count (CBC) with platelets less than 4.0 times below or above the upper or lower limit range
  • Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit range
  • Eligible adult patients currently meeting inclusion criteria and will be treated with an investigational or recently approved therapeutic agent at HCI; the patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; RECIST imaging must be current and have been obtained within 30 days prior to the baseline imaging session
  • Prothrombin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time must not exceed 6 times the upper limit of the normal range
  • Serum glutamate pyruvate transaminase (SGPT) less than 4.0 times below or above the upper or lower limit range
  • Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range
  • Total bilirubin less than 4.0 times below or above the upper or lower limit range
  • Serum electrolytes less than 4.0 times below or above the upper or lower limit range
  • Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range
  • Partial thromboplastin time less than 2.5 times below or above the upper or lower limit range; for those patients receiving Coumadin or another anticoagulant the upper limit for partial thromboplastin time must not exceed 6 times the upper limit of the normal range
  • Blood urea nitrogen (BUN) less than 4.0 times below or above the upper or lower limit range
  • Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging

Exclusion

  • Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
  • Patients known to be human immunodeficiency virus (HIV) positive
  • Adult patients who require monitored anesthesia for PET scanning
  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion