Adaptive Pet Study
|ClinicalTrials.gov Identifier: NCT01908504|
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : December 8, 2017
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Measure late toxicities [ Time Frame: 3 years ]Subjects will be evaluated in regular follow up with measures of treatment related side effects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908504
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Junzo Chino, MD||Duke University|