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Adaptive Pet Study

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01908504
Collaborator
(none)
271
Enrollment
1
Location
1
Arm
56
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: PET-CT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
271 participants
Allocation:
N/A
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 :
Jan 1, 2012
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. The number of subjects with benefit from an intra-treatment PET-CT [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. [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 [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) [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 [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 [3 years]

    Subjects will be evaluated in regular follow up with measures of treatment related side effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Junzo Chino, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT01908504
Other Study ID Numbers:
  • Pro00033339
First Posted:
Jul 25, 2013
Last Update Posted:
May 8, 2019
Last Verified:
May 1, 2019
Additional relevant MeSH terms:
Esophageal Neoplasms
Endometrial Neoplasms

Study Results

No Results Posted as of May 8, 2019