Trial record 1 of 4 for:    FDG-PET for the Delivery of Adaptive Radiation Therapy
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Adaptive Pet Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01908504
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.

Condition or disease Intervention/treatment
Head and Neck Cancers Lung and Esophagus Cancers Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers Other: PET-CT

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
Study Start Date : January 2012
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
At radiation planning subjects will have a PET-CT. The CT scan — also called computerized tomography or just CT — combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.

Primary Outcome Measures :
  1. The number of subjects with benefit from an intra-treatment PET-CT [ Time Frame: 3 years ]
    This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.

Secondary Outcome Measures :
  1. Locoregional control. [ Time Frame: Day of intra treatment PET-CT/ approx 2-4 hours ]
    This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.

  2. Freedom from distant metastases [ Time Frame: 3 years ]
    Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.

  3. Measure overall survival (OS) [ Time Frame: 3 years ]
    Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site.

  4. Measure acute toxicities [ Time Frame: During radiation therapy and within 30 days of the last radiation treatment ]
    Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.

  5. Measure late toxicities [ Time Frame: 3 years ]
    Subjects will be evaluated in regular follow up with measures of treatment related side effects.

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

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of carcinoma
  • Patients with local or regional nodal disease are eligible.
  • Zubrod Performance Status 0, 1, or 2.
  • Age ≥ 18
  • Negative serum pregnancy test for women of child bearing potential
  • Patient must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

  • No gross disease visible on imaging at the start of radiotherapy
  • Contraindication to PET
  • Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
  • Breast feeding

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 identifier (NCT number): NCT01908504

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Junzo Chino, MD Duke University

Responsible Party: Duke University Identifier: NCT01908504     History of Changes
Other Study ID Numbers: Pro00033339
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Esophageal Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female