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Multi-Tracer PET in Early Phase Trials

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ClinicalTrials.gov Identifier: NCT01243333
Recruitment Status : Recruiting
First Posted : November 18, 2010
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
University of Utah

Brief Summary:
The treatment of cancer is increasingly aimed at molecular targets derived from studies of the oncogenes and tumor suppressors known to be involved in the development of human cancers. The increased specificity obtained from these new targeted treatments has developed over the past many decades. From the use of general cytotoxic agents such as nitrogen mustard in the 1940s, to the development of natural-product anticancer drugs in the 1960s including the Vinca alkaloids and anthracyclines there has been improvements in cancer chemotherapy. Early in the development process drugs were used that were found to be more cytotoxic to cancer cells than normal cells. Later developments included the use of specific monoclonal antibodies and immunotoxins targeted to cell surface receptors. In addition, as our knowledge of molecular biology increased, specific agents that inactivate kinases in growth-promoting pathways were used to treat cancer. These newer more targeted approaches have improved the response rate in cancer and reduced side effects of anticancer treatment but have not yet resulted in cures for the majority of patients with metastatic disease. There are general broad classifications of chemotherapeutic drug effects. One of the earliest and still most utilized are the cytotoxic chemotherapeutic agents.

Condition or disease Intervention/treatment
Cancer Radiation: Multi-tracer PET exams

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Tracer PET (Positron Emission Tomography) Assessment of Response in Various Malignancies in Investigational and Recently Approved Therapeutic Agents
Study Start Date : February 2011
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Intervention Details:
    Radiation: Multi-tracer PET exams
    Initial scan will be done before starting the trial. The other two will be done about 25 to 32 days after the trial starts. Each of the 4 PET scans will be done with up to three of the tracers (FDG, FLT, and water) depending on the type of drug they are receiving and the tumor type. The timing of the PET scans will vary. Typically the first series of PET scans will be within a few days of each other but will be obtained within one week of each other. Similarly the follow-up series of PET scans at about 28 days will be within a few days of each other depending on scheduling issues but also within one week of each other.

Primary Outcome Measures :
  1. Prediction of early response using Multi-tracer positron emission tomography (PET)imaging versus standard imaging techniques [ Time Frame: estimated 2 years ]
    We hypothesize that by using a set of imaging derived biomarkers we can predict response, either a prior or at an earlier time point than would normally be determined with standard imaging techniques such as a CAT Scan (CT) in patients with various malignancies.

Secondary Outcome Measures :
  1. Establishment of PET Biomarkers as a determinate of clinical benefit [ Time Frame: estimated 4 years ]
    Provide reliable validated cadre of PET imaging derived biomarkers that yield a better understanding of early clinical benefit from various therapeutic agents, efficacy during therapeutics early phase clinical trials, possible predict prognosis or other long term outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This companion clinical study is designed to obtain pre-therapeutic imaging assessments using positron emission tomography (PET) imaging in 50 evaluable patients (those patients who had baseline and followup PET imaging) with various forms on malignancy and at approximately 28 days (day 25 -32), after institution of the therapeutic drug from various primary therapeutic clinical trials.

Inclusion Criteria:

  1. Eligible Adult patients currently meeting inclusion criteria and will be treated with an investigational or recently approved therapeutic agent at HCI.
  2. Patients must be 18 years or older for inclusion in this research study.
  3. 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.
  4. All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
  5. 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.
  6. Pre-treatment laboratory tests for patients receiving [18F]FLT must be performed within 21 days prior to study entry.

Exclusion Criteria:

  1. Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
  2. Patients who are pregnant or lactating or who suspect they might be pregnant.
  3. Adult patients who require monitored anesthesia for PET scanning.
  4. Patients known to be HIV (human immunodeficiency virus) positive. This is due to the potential toxicities of FLT in HIV positive patients

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

Contact: Paige Nielsen 801-213-4218 paige.nielsen@hci.utah.edu
Contact: britney beardmore 801-587-4798 britney.beardmore@hci.utah.edu

United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: John M Hoffman, MD         
Sponsors and Collaborators
University of Utah
Principal Investigator: John M Hoffman, MD University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01243333     History of Changes
Other Study ID Numbers: HCI43948
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by University of Utah:
cancer, imaging