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Multi-Tracer Positron Emission Tomography in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT01243333
Recruitment Status : Active, not recruiting
First Posted : November 18, 2010
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Radiation: Fludeoxyglucose F-18 Other: Fluorothymidine F-18 Procedure: Positron Emission Tomography Radiation: Water O-15 Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Provide a reliable and validated cadre of positron emission tomography (PET) imaging derived biomarkers that yield a better understanding of: 1) early clinical benefit from various therapeutic agents in investigational and recently approved therapies; 2) efficacy during novel therapeutics in investigational therapeutics and recently approved therapeutics at Huntsman Cancer Institute (HCI); and 3) possible predict prognosis or other long-term outcomes.

II. Reveal a more detailed understanding of: (1) the in vivo biologic mechanisms of various therapeutic drugs in investigational therapies and recently approved therapies at HCI (2) information on why particular functional imaging profiles are seen in treated patients.

III. Reveal a more detailed understanding of how the combination of molecular imaging derived biomarkers will be potentially useful to physicians for decision making and for explanation of efficacy or outcomes for patients with cancer.

IV. Implement and evaluate a new imaging technology for multi-tracer PET imaging of these tracers.

OUTLINE:

Patients undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-tracer PET Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents
Actual Study Start Date : January 26, 2011
Actual Primary Completion Date : March 6, 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diagnostic (multi-tracer PET scans)
Patients undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers at baseline and within 7 days of completion of 1 or 2 (if the course is less than 3 weeks) therapeutic agent courses.
Radiation: Fludeoxyglucose F-18
Undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Other: Fluorothymidine F-18
Undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers
Other Names:
  • 18F-FLT
  • 3'-Deoxy-3'-(18F) Fluorothymidine
  • 3'-deoxy-3'-[18F]fluorothymidine
  • ALOVUDINE F-18
  • fluorothymidine F 18
Procedure: Positron Emission Tomography
Undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Radiation: Water O-15
Undergo PET scans with fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15 tracers
Other Names:
  • [15O] Water
  • [15O]-H2O



Primary Outcome Measures :
  1. Percent change in composite standardized uptake value (SUV) [ Time Frame: Baseline to 28 days ]
    Separate mixed effects models for each imaging parameter will be used to compare regions of interest (ROIs) from responders and non-responders. These models will have a random effect to account for within-patient correlation, and a fixed effect for response group. Standard descriptive statistics such as means, standard deviations, ranges and Pearson correlation, will be used to summarize study parameters.


Secondary Outcome Measures :
  1. Percent change in rate parameters [ Time Frame: Baseline to 28 days ]
    Separate mixed effects models for each imaging parameter will be used to compare ROIs from responders and non-responders. These models will have a random effect to account for within-patient correlation, and a fixed effect for response group. Standard descriptive statistics such as means, standard deviations, ranges and Pearson correlation, will be used to summarize study parameters.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
  • All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  • 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
  • Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit 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
  • Lactate dehydrogenase (LDH) 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
  • Complete blood count (CBC) with platelets less than 4.0 times below or above the upper or lower limit range
  • 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
  • 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
  • Creatinine less than 4.0 times below or above the upper or lower limit range
  • 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

Exclusion Criteria:

  • 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
  • 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
  • Adult patients who require monitored anesthesia for PET scanning
  • Patients known to be human immunodeficiency virus (HIV) positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243333


Locations
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: John Hoffman Huntsman Cancer Institute/ University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01243333     History of Changes
Other Study ID Numbers: HCI43948
NCI-2011-03665 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Neoplasms
Fluorodeoxyglucose F18
Fluorides
Dideoxynucleosides
Alovudine
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents