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Completed

NCT Number: NCT01908504

Adaptive Pet Study

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.

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Key information

Conditions

Head and Neck Cancers Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Lung and Esophagus Cancers Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-CT

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2013
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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