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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01908504
First received: July 19, 2013
Last updated: June 1, 2017
Last verified: June 2017
  Purpose
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 Intervention
Head and Neck Cancers Lung and Esophagus Cancers Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers Other: PET-CT

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 320
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET-CT Other: PET-CT
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908504

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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01908504     History of Changes
Other Study ID Numbers: Pro00033339
Study First Received: July 19, 2013
Last Updated: June 1, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017