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Multi-Tracer PET in Early Phase Trials

This study is currently recruiting participants.
Verified April 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01243333
First received: November 1, 2010
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Cancer
 Radiation: Multi-tracer PET exams

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Tracer PET (Positron Emission Tomography) Assessment of Response in Various Malignancies in Early Phase Therapeutic Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Prediction of early response using Multi-tracer positron emission tomography (PET)imaging versus standard imaging techniques [ Time Frame: estimated 2 years ] [ Designated as safety issue: No ]
    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:
  • Establishment of PET Biomarkers as a determinate of clinical benefit [ Time Frame: estimated 4 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.
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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 100 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 various primary therapeutic clinical trials.

Criteria

Inclusion Criteria:

  1. Eligible Adult patients currently meeting inclusion criteria and have enrolled in an IRB approved early phase (Phase I, Phase I/II, or Phase II) clinical trial at HCI.
  2. Patients must be 18 years or older for inclusion in this companion research study.
  3. Patients must document their willingness to be followed for the period of time defined by the therapeutic clinical trial.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243333

Contacts
Contact: Kelli Rasmussen 801-213-4218 kelli.rasmussen@hci.utah.edu
Contact: britney beardmore 801-587-4798 britney.beardmore@hci.utah.edu

Locations
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
Investigators
Principal Investigator: John M Hoffman, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01243333     History of Changes
Other Study ID Numbers: HCI43948
Study First Received: November 1, 2010
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
cancer, imaging

ClinicalTrials.gov processed this record on May 16, 2013